RELAY Plus® Thoracic Stent-Graft Systemwith Transport® Delivery System

RELAY Plus® Sistema di endoprotesi toracicacon sistema di rilascio Transport®

RELAY Plus® Thorakaler Stentgraft mit Transport®

-Einführungssystem GEBRAUCHSANWEISUNG

Greffon-extenseur thoracique RELAY Plus® avec système de mise en place Transport®

RELAY Plus® thoracale stentgraftsysteemmet Transport®-plaatsingssysteem

RELAY Plus® Thoracic Stent-Graft Systemmed Transport® Delivery System

RELAY Plus® torakalt stentgraftsystemmed Transport® insättningssystem

Sistema de endoprótese revestida torácica RELAY Plus®

com sistema de colocação Transport®

Sistema de Endoprótesis Torácica RELAY Plus®

con Sistema de Liberación Transport®

RELAY Plus® Mellkasi sztent-graft rendszerTransport® bevezetőrendszerrel

RELAY Plus® -rintastenttiproteesi jaTransport®-asennusjärjestelmä

Systém hrudního stentgraftu RELAY Plus® se zaváděcím systémem Transport®

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Stentgraft piersiowy RELAY Plus® z zestawemwprowadzajacym Transport®

RELAY Plus®

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TABLE OF CONTENTS

Section Page

DEVICE DESCRIPTION 8

RADIOPAQUE MARKER BANDS 8

RELAY PLUS® TRANSPORT® DELIVERY SYSTEM 8

INDICATIONS FOR USE 8

CONTRAINDICATIONS 9

WARNINGS AND PRECAUTIONS 9

HOW PRODUCT IS SUPPLIED 10

DEVICE SELECTION 10

CASE PREPLANNING / INDIVIDUALIZATION OF TREATMENT 11

EQUIPMENT REQUIREMENTS 11

THE IMPLANTATION PROCEDURE 12

MAGNETIC RESONANCE SAFETY INFORMATION 15

ADVERSE EVENTS 16

SYMBOLS/DEFINITIONS AND COMPANY ADDRESSES 16

RELAY Plus® Thoracic Stent-Graft Systemwith Transport® Delivery System

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DEVICE DESCRIPTION

The RELAY Plus® Endoluminal Stent-Graft System is an endovascular device intended to treat thoracic aortic pathologies. The RELAY® Stent-Graft is comprised of Duralloy®, self-expanding nitinol, stents sutured to polyester vascular graft fabric. The stent scaffold is a series of serpentine springs stacked in a tubular configuration. These stents are spaced along the length of the graft fabric. Longitudinal support for the stent-graft is provided by a curved nitinol wire called Spiral Support Strut. Additionally, radiopaque markers are placed on the stent-graft to aid visualization and accurate placement.

RELAY® Stent-Graft end configuration:

One proximal end configuration is available:The SAFEX® end configuration (Fig 1) consists of uncovered, sinusoidal nitinol wires of varying heights; circumferentially projecting above the fabric end of the graft. These uncovered wires when in position, expand to the vessel wall anchoring the device in place and aid in creating a seal zone oriented to the vasculature. Secondly, this design is placed across vessels maintaining patency, i.e. left subclavian/ left common carotid arteries, and increasing the landing zone area.

One distal configuration is also available. The STRAIGHT end configuration (Fig 1) consists of fabric covering the nitinol springs evenly about the circumference of the stent-graft. This configuration is present distally on all Stent-Grafts.

1. Proximal Marker2. Spiral Support Strut Marker3. Spiral Support Strut4. Distal Marker5. Safex® Stent6. Safex® End Configuration7. Freeflex®8. Straight End Configuration

RADIOPAQUE MARKER BANDS

All stent stent-grafts will have platinum/iridium radiopaque marker bands (See Fig 1) which will indicate the fabric edge and will also serve as guides for positioning the spiral support strut.

RELAY PLUS® TRANSPORT® DELIVERY SYSTEM

The RELAY Plus® Transport® delivery system consists of a series of coaxially arranged sheaths and catheters, along with a tubular handle control system. The delivery mechanism consists of two stages. The first stage consists of a hydrophilically coated introducer (Outer Primary Sheath), which is used to advance and track over a guidewire. The tip of the Outer Primary Sheath contains a preformed curve. Within the first stage is the second stage. The second stage is a flexible sheath in which the stent-graft is compressed. The flexibility of the second stage permits tracking through tortuous and curved portions of the thoracic aorta. The stent-graft is self-expandable and the delivery system is withdrawn after deployment.

INDICATIONS FOR USE

The RELAY® stent-graft is intended for the treatment of thoracic aortic pathologies such as aneurysms, pseudoaneurysms, dissections, penetrating ulcers and intramural hematoma, in adult patients (as defined by local statutes). Anatomical/Sizing features specified in Tables 1, 2 and 3 should be observed.

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1. Delivery System Tip2. Apex Holder3. Inner Secondary Sheath4. Outer Primary Sheath5. Radiopaque Marker6. Stationary Grip7. Shipping Retainer8. Main Body9. Flush Port/Stopcock

10. Deployment Grip11. Controller12. Stainless Steel Rod13. Apex Release Retainer14. Apex Release Grip15. Guidewire Luer16. Flushport17. Handle Body Mark

CONTRAINDICATIONS OF USE FOR THE RELAY PLUS® SYSTEM

The RELAY Plus® System is contraindicated when patients present with any of the following characteristics/conditions: • Pregnancy/lactation.• Aneurysm/lesion location not accessible to the delivery system and stent placement.• Arterial access size insufficient for delivery system entrance.• Treatment of lesion that would require a delivery system with usable length greater than 90 cm.• Excessive arterial disease precluding delivery system entrance or passage.• Untreatable allergy or history of allergic reaction to radiographic contrast media (x-ray dye).• Untreatable allergy or history of allergic reaction to anticoagulants.• Systemic infection.• Arterial tortuosity not allowing passage of the delivery system.• Arterial or aneurysm/lesion size incompatible with stent graft.• Has congenital connective tissue disease rendering the aneurysm/lesion untreatable.• Mycotic aneurysm/lesions.• Aortic inner diameter that cannot accommodate the expanded Inner Secondary Sheath outer diameter of

approximately 12mm.• Thoracoabdominal aneurysms.• Hypersensitivity to polyester or nitinol.• Massive thrombus.• Bleeding diathesis.

WARNINGS AND PRECAUTIONS

• Placement of stent grafts in the thoracic aorta often requires proximity to the great vessels perfusing the brain increasing the possibility of thrombus or embolization proximally. Care should be taken to ensure air has been purged from the system.

• Proximal and distal required landing zones vary with stent-graft size (See Table 2).• Excessive aortic tortuosity may result in not being able to properly position the stent graft or stent graft

kinking with thrombus formation.• If balloon modeling is desired, use a compliant balloon equal in size to the largest diameter stent graft used.

Balloon inflation should not exceed 1 atm.• Do not use power/pressure injections through the Transport® delivery system.• Care should be taken with respect to occlusion of dominant intercostals/spinal cord arteries.• Care should be taken when treating morbidly obese patients as visualization of imaging may be compromised.• Careful consideration should be given to treating patients where tracking through a previously placed

endovascular or surgical prosthesis is required.• Given the contraindication for pregnant or lactating women, care should be taken when treating women of

childbearing potential.• Consideration should be given to treating patients with significant comorbidities/high risk for open surgical repair.

* In selected circumstances, the benefits of this procedure may outweigh possible risks.

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HOW PRODUCT IS SUPPLIED

The RELAY Plus® Thoracic Stent-Graft System with Transport® delivery system is provided STERILE.

DO NOT RESTERILIZE-SINGLE USE ONLY.

Re-sterilization of the device for re-use will result in loss of component integrity (e.g., reduction of stent-graftradial force, component cracking or discoloration, etc.).Do not reuse, reprocess, clean/disinfect, or re-sterilize. Reuse, reprocessing, cleaning/disinfection, or re-sterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in deterioration of health or death of patients or users. Reuse, reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to the transmission of infections disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient end-user. Also, each single-use device carries specific labeling instructions relative to storage, use and handling to minimize exposure to conditions, which could compromise the product, the patient or the user. These conditions cannot be assured once the packaging is opened and discarded.

The RELAY® endoluminal straight thoracic stent-grafts are available in 4 approximate lengths:• 100 mm • 150 mm • 200 mm • 250 mmThe straight grafts are available in 2 mm incremented diameters ranging from 22 mm to 46 mm. Tapered stent-grafts are available with proximal diameters ranging from 28 mm to 46 mm, decreasing incrementally by 4 mm over the length of the stent-graft.

The product is supplied with the following model designation identified on the label.

DEVICE SELECTION

Tables 1 & 3 address the selection of the appropriate stent-graft diameters for the RELAY®: Table 2 addresses the recommended healthy landing zone length depending on stent-graft diameter selected.

STRAIGHT STENT-GRAFTS (Table 1.)

*Special order

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TARGET LANDING ZONE (Table 2.)

TAPERED STENT-GRAFTS (Table 3.)

CASE-PREPLANNING/INDIVIDUALIZATION OF TREATMENT

Practitioners using the RELAY Plus® Transport® delivery device should have a thorough understanding of endovascular procedures and techniques. In particular, the RELAY Plus® device should only be used by physicians and teams with experience and training in vascular interventional techniques, including, but not limited to, training on the use of the RELAY Plus® Transport® delivery system. This will include practitioners with formal education/training in vascular surgery, interventional radiology, cardiothoracic surgery and interventional cardiology.

Selecting the proper stent-graft with the appropriate length and diameter is paramount to the successful exclusion of the indicated thoracic aortic pathologies. Measure all parameters needed for proper sizing of the stent-graft carefully. Bolton Medical recommends evaluation of all imaging studies available, i.e., angiograms, CT scans, MRI scans, MRA scans and plain radiographs. Each imaging modality offers additional information to the sizing process. The physical characteristics of the vessel should be evaluated in addition to its size. Factors such as stenosis, atherosclerotic disease, ectasia and tortuosity may affect stent-graft selection and placement strategy. The final stent-graft selection will be the responsibility of the physician.

Practitioner must ensure that the access vessel diameter is compatible with the selected delivery system’s Outer Primary Sheath French size. The physician and patient (and/or family) should review the risks and benefits when discussing this endovascular device and the need for compliance with follow ups. Any pertinent actions to be avoided or precautions to be taken should also be discussed.

EQUIPMENT REQUIREMENTS

Fluoroscopic equipment including a high resolution image intensifier on a freely angled C-arm which can be ceiling or pedestal mounted or portable will be needed for the procedure. It is desirable if the image intensifier has a complete range of motion to achieve AP projections to lateral projections. Its capabilities should include:

• Digital Subtraction Angiography• High resolution angiography• Roadmapping

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ThoracicAorta Proximal

Vessel Size(mm)

Stent-graft Size

(mm)

Percent ofStent-graft

Oversize (%)

Outer Primary Sheath French Size (O.D.) (3 FR = 1 mm)

100mmStent-graft

(FR)

150mmStent-graft

(FR)

200mmStent-graft

(FR)

250mmStent-graft

(FR)

Stent-graft Diameter Proximal Length

22-28 mm30-38 mm40-46 mm

15 mm20 mm25 mm

Fever

Post Implantation Syndrome

Hematoma

Blood Loss

Hemorrhage

Infection

Cardiac events

Anaphylaxsis

Vessel Dissection

Vessel Occlusion/Thrombosis

Vessel Damage

Emboli

Hepatic failure

Ischemia (spinal cord, perfusion pathways)

Renal failure or Complications

Aneurysm / Lesion Rupture

Arteriovenous fistula / aorto-esophageal fistula

Radiation overexposure or reaction

Pseudoaneurysm

Transient ischemic Attack

Cerebral vascular accident (stroke)

Congestive heart failure

Paralysis/Paresthesia/Paraparesis

Death

Incision Site Complications

Limb ischemia

Delivery system failure

Access failure

Stent graft misplacement

Endoleak

Stent graft migration

Stent graft failure

Wire form fractures

Suture fracture

Deployment failure

Perforation

Device dehiscence

Stent-graft tearing/wear

ProductID

28

DeviceType

DesignModification

Number

StentDiameterProximal

StentCoveredLength

StentDiameter

Distal

DeliverySystem

French Size

DeliverySystemusableLength

DeviceDesignation

M: Main 3 XX XXX XX XX XX S: StandardCatalog Product

28x2430x2632x2834x3036x3238x3440x3642x3844x4046x42

Stent-graft Covered Length

150mmStent-Graft

24-2525-2728-2930-3132-33

3435-3637-3839-4041-42

20-2122-2324-2526-2728-2930-3132-33

3435-3637-38

12-1711-1510-149-139-1211

11-1410-1310-139-12

14-2013-1812-1711-1510-149-139-1211

11-1410-13

164164164154154154154159164164

204209209209199199204204209209

259259259259259259259259259259

22222323242425252526

22232324242525252526

23232424252525252626

200mmStent-Graft

250mmStent-Graft

150mmStent-Graft(FR)

200mmStent-Graft(FR)

250mmStent-Graft(FR)

Outer Primary SheathFrench Size (O.D.)

ThoracicTaperStent-

Graft Size(mm)

Proximal Distal Proximal Distal

Thoracic VesselSize (mm)

Percent of Stent-Graft Oversize (%)

Stent-graft Diameter Distal Length

22-28 mm40-46 mm

15 mm25 mm

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Thoracic Vessel Percent of Stent- Outer Primary Sheath Stent-Graft Covered Length Stent-Graft Total Length Size mm Graft Oversize (%) French Size (O.D.)

150 mm 200 mm 250 mm 150 mm 200 mm 250 mm 150 mm 200 mm 250 mm Proximal Distal Proximal Distal Stent- Stent- Stent- Stent- Stent- Stent- Stent- Stent- Stent- Graft Graft Graft Graft Graft Graft Graft Graft Graft

ThoracicTaper Stent-

Graft size(mm)

28x24 24-25 20-21 12-17% 14-20% 155mm 195mm 250mm 170mm 210mm 265mm 22Fr 22Fr 23Fr

30x26 25-27 22-23 11-15% 13-18% 155mm 200mm 250mm 171mm 216mm 266mm 22Fr 23Fr 23Fr

32x28 28-29 24-25 10-14% 12-17% 155mm 200mm 250mm 172mm 217mm 267mm 22Fr 23Fr 24Fr

34x30 30-31 26-27 9-13% 11-15% 145mm 200mm 250mm 162mm 217mm 267mm 23Fr 24Fr 24Fr

36x32 32-33 28-29 9-12% 10-14% 145mm 190mm 250mm 163mm 208mm 268mm 24Fr 24Fr 24Fr

38x34 34 30-31 11% 9-13% 145mm 190mm 250mm 164mm 209mm 269mm 24Fr 25Fr 25Fr

40x36 35-36 32-33 11-14% 9-12% 145mm 195mm 250mm 165mm 215mm 270mm 25Fr 25Fr 25Fr

42x38 37-38 34 10-13% 11% 150mm 195mm 250mm 170mm 215mm 270mm 25Fr 25Fr 25Fr

44x40 39-40 35-36 10-13% 11-14% 155mm 200mm 250mm 176mm 221mm 271mm 25Fr 25Fr 26Fr

46x42 41-42 37-38 9-12% 10-13% 155mm 200mm 250mm 176mm 221mm 271mm 26Fr 26Fr 26Fr

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Supportive/supplementary equipment:

• .035” (0,89 mm)/300 cm Meier guidewire• .035” (0,89 mm)/260 cm or 300 cm Lunderquist guidewire• Guidewire torque device• Inflation device with pressure gauge• Aortic occlusion balloons• Compliant stent graft modeling balloons of the appropriate size• Arterial puncture needles 18G or 19G• Nitinol goose neck snare (10-15 mm diameter)• Assortment of vascular stents• Assortment of angiographic and graduated pigtail catheters

Anticoagulation and antiplatelet therapies are performed at the discretion of the physician. Similarly, blood pressure adjustment and spinal cord protection measures are also at the discretion of the physician.

THE IMPLANTATION PROCEDURE

PREPARATION (Steps 1 through 7)

Position the patient on the surgical table where standard aseptic preparation of the surgical site is conducted. (Ensure that a compliant stent graft modeling balloon of the appropriate size is available if needed. Do not exceed 1 atm pressure with balloon).

If a radiopaque ruler is to be used, place it underneath the patient at this time. Drape the patient with sterile surgical drapes leaving exposed the bilateral groin access sites.

1. Verify devices are correct for the patient.

2. Inspect the system packaging for visible tears, breaks or openings. 3. Take the Transport® delivery system from the sterile packaging and bring it to the surgical table. Examine the Transport® delivery system for structural integrity. DO NOT USE the system if defects are noted.

4. Perform a percutaneous needle puncture of the contralateral common femoral artery. Using the Seldinger technique, place a guidewire well into the abdominal aorta. Remove the needle and place a vascular introducer over the guidewire into the artery. Advance a 5FR (1,7mm) pigtail angiographic catheter over the guidewire to the level of the aortic arch. Remove the guidewire.

Perform an arteriotomy of the ipsilateral common femoral artery using umbilical ties or surgical vessel loops for hemostatic control. Introduce a .035”(0,89mm) guidewire into the artery and advance it to the aortic arch.

NOTE: Ensure that the controller in the “1” position, if it is not change it to the “1” position (aligned with the arrow in Fig 3). To change position, push Controller toward the Main Body Handle and rotate to desired position, then release.

Check the distal end of the delivery system to ensure that the Delivery System Tip is properly seated in the Outer Primary Sheath (Fig. 4). If not, correct by moving the Deployment Grip until the Delivery System Tip is properly seated as shown in Fig. 4. Ensure that the tip side hole is not covered by the Outer Primary Sheath (Fig. 4).

5. Keep the controller in the “1” position to prevent premature deployment of the stent graft. Check that the Shipping Retainer covers the delivery system Main Body. The Shipping Retainer aids in preventing premature release of the stent graft from the outer sheath.

WARNING: Do not remove the Shipping Retainer until the inner secondary sheath is to be advanced out of the outer primary sheath!!!

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6. Remove silicone tubing from the Flush Port (Fig. 5a). Flush the delivery system with heparinized saline through the Flush Port (Fig 5b) to purge air from the coaxially situated sheaths. Ensure that a continuous stream of saline exits the tip side hole (Fig 4). It may be necessary to elevate the distal end of the system to different positions to bring air to the highest point for purging. The flush port valve must be closed under pressure to prevent air from re-entering the system. Visually inspect it for remaining air and repeat if necessary. Then flush through the guidewire luer and Flush Port extension tubing (Fig 5c). Remove extension tubing after flushing.

7. Important: Activate the hydrophilic coating by wetting the Tip and Introducer Sheath with saline.

INTRODUCTION/ADVANCEMENT (Steps 8 through 17)

8. While holding and directing the introducer sheath with one hand and holding the distal handle grip with the other hand, advance the introducer sheath into the artery over the guidewire. The guidewire should always remain in the delivery system while inside the patient.

9. Under fluoroscopic control, advance the Outer Primary Sheath until the Delivery System Tip is just below the intended distal landing zone. If the aorta presents tight tortuosity, the tip should be advanced past the tight curvature(s) of the descending aorta to facilitate navigation of the secondary stage/inner sheath. Do not advance the outer primary sheath into the thoracic arch.

If the Outer Primary Sheath cannot be advanced beyond the region of tight curvatures the delivery system should be removed from the patient and an alternate procedure be considered.

10. To advance the secondary inner sheath out of the outer primary sheath, remove the Shipping Retainer from the main body by grasping the fabric tab and pulling it away from the handle body (Fig. 5d).

Once the secondary inner sheath is advanced, the user will be committed to implant the graft.

CAUTION: The Controller must be in the “1” position.

11. While holding the black Stationary Grip so that the Main Body remains stationary, push the gray Deployment Grip forward (towards the Stationary Grip) until the stent-graft’s proximal markers reach the proximal landing zone.

Verify that the gray Deployment Grip has reached or passed the black Handle Body mark on the main handle body (Fig. 6b). This will ensure that the Inner Secondary Sheath has completely exited the Outer Primary Sheath (Fig 6a). Also, the distal stent marker bands will be seen approximately 2cm out of Primary Outer Sheath.

If the gray Deployment Grip has not reached or passed the black Handle Body mark while the controller is still in position 1, hold the gray Deployment Grip stationary while pulling the Stationary Grip distally until the gray Deployment Grip reaches or passes the black Handle Body mark, this will ensure that the secondary inner sheath is fully out of the outer sheath.

12. As the Inner Secondary Sheath is advanced out of the Outer Primary Sheath, note the alignment of the Spiral Support Strut by locating the Spiral Support Strut markers under fluoroscopy.

13. Place the C-Arm DSA system into a left anterior oblique position in preparation for the initial angiogram. Check the patient image for the possibility of image corruption such as parallax or image distortion by the fluoroscopic x-ray beam divergence. The central ray should be perpendicular to the area of interest. If the device is to be implanted in a curved section of the aorta, verify that the D-shaped marker on the inner secondary sheath and the Spiral Support Strut marker(s) face the greatest curvature. If radial adjustment is needed, retract the deployment grip to bring the stent-graft to a straight portion of the vessel. When retracting the gray deployment grip, ensure that the distal end of the stent-graft is not pulled into the outer primary sheath (the black Handle Body mark can be used as a reference). It may be necessary to withdraw the whole device a few centimeters to bring the stent-graft to a straight position.

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After the stent-graft is in the straight position, while holding the stationary grip, rotate the gray deployment grip to manually align the Spiral Support Strut markers toward the greatest curvature of the aorta. The D-shaped marker can be used to aid in this placement (Fig 7). If the round portion of the D-shaped marker is facing the greater curvature, the gray deployment grip should be turned clockwise. If the round portion is facing the lesser curvature the turn should be counterclockwise. One to three handle revolutions maybe required before the stent-graft begins rotating.

14. Perform an angiogram of the area of interest and mark the target area.

15. Ensure that the surgical table and patient are locked into position.

16. Finalize the longitudinal placement of the stent-graft in relation to the proximal landing zone by adjusting the gray deployment grip as necessary. Confirm the position of the proximal and distal marker bands as well as the Spiral Support Strut markers.

If the gray Deployment Grip reaches its maximum travel before the stent graft reaches the landing zone, the whole device should be advanced. Before advancing the whole device, the gray Deployment Grip should be retracted so as to re-capture the distal stent within the outer primary sheath. At this point, the entire delivery system is advanced as needed.

Since the distal stent is captured within the outer primary sheath, the gray deployment grip should be advanced once more until the stent graft reaches the proximal landing zone and the distal stent is out of the outer primary sheath. Ensure the gray deployment grip has reached or passed the black Handle Body mark.

DEPLOYMENT (Steps 18 through 20)

17. With the stent graft in the desired deployment position, turn the Controller to the “2” position (Fig. 8).

CAUTION: Verify that the Controller is in the “2” position during steps 18 through 23.

18. While holding the Stationary Grip fixed, retract the Deployment Grip (Fig 9a) by pulling down the Inner Secondary Sheath and exposing the bare stent and the first covered stent.

NOTE: The Inner Secondary Sheath has the D-Shaped radiopaque marker (See Fig 2, Transport® drawing) located at its distal end that can be used to visualize its movement under fluoroscopy.

19. Make any final linear position adjustments (proximally or distally) by first changing the controller to position 1. Then using the gray Deployment Grip, move the stent graft proximally or distally to the desired location. After the stent graft is in the desired location, move the controller setting back to position 2.

RELEASE (Steps 20 through 23)

20. To release and deploy the stent graft, completely retract the Inner Secondary Sheath by holding the Stationary Grip fixed and retracting the deployment grip with one continuous motion without stopping until the stent graft is fully deployed (Fig 9b).

CAUTION: Failure to promptly deploy the stent graft will cause blood pressure to increase and may result in distal migration of the device during deployment.

21. Maintain attachment of the proximal end of the stent graft by the Apex Holder. To release the stent graft from the Apex Holder, go to the thumbscrew on the Apex Release Retainer. Loosen the thumbscrew by rotating counterclockwise 2-3 turns (Fig 10).

22. Lift and remove the Apex Release Retainer.

23. Under fluoroscopic control, release the Safex® stent (bare spring apexes) by pulling the Apex Release Grip (Number 3, Fig 11) towards the Guidewire Luer until it reaches the end of the Stainless Steel Rod. The stent graft is now in final position (Fig 11).

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CONCLUSION AND REMOVAL (Steps 24 through 31)

24. Place the Controller in the “4” position.

25. Retract the Stainless Steel Rod by pulling it completely distal, allowing the tip to rejoin the outer sheath (Fig 12).

CAUTION: Perform this step carefully and under fluoroscopic control, monitoring the travel of the Delivery System Tip through the deployed stent-graft so that stent graft’s position is not affected. If the tip does not reseat easily, apply slightly greater force until the tip seats properly.

26. Withdraw the entire system from the patient.

27. Perform a final angiogram to assess for any endoleaks and/or migration. Confirm successful aneurysm/lesion exclusion.

28. If an endoleak is detected, consider balloon modeling to correct the leak.

CAUTION: Do not exceed 1 atm. Balloon pressure. Always recheck position of stent graft following ballooning.

29. Straighten the angiographic pigtail catheter and remove the catheter and sheath from the percutaneous puncture site.

30. Perform standard surgical closure of the arteriotomy site.

31. Assess blood flow to the distal extremities.

MAGNETIC RESONANCE SAFETY INFORMATION

The RELAY® stent-graft was determined to be MR-conditional. Specifically, when present in a patient undergoing a magnetic resonance imaging (MRI) procedure at 3-Tesla or less will not create an additional hazard or risk to the patient under the conditions used for the testing.

Magnetic resonance imaging (MRI) procedures must be performed according to the following guidelines:

• A patient with the RELAY® stent-graft may safely undergo an MRI procedure using an MR system with a static magnetic field of 3-Tesla or less. The RELAY® stent-graft system does not exhibit magnetic field interactions with respect to translational attraction (tested at a maximum spatial gradient, 3.3-Tesla/meter) and showed no torque during exposure to a 3-Tesla MR system. Therefore, there is no additional risk to a patient with the RELAY® stent-graft with respect to movement or dislodgement using an MR system with a static magnetic field of 3-Tesla or less. In addition, because of the lack of magnetic field interactions at 3-Tesla, an MRI procedure may be performed on a patient immediately after implantation of the RELAY® stent-graft.

• MRI procedures must not exceed exposures to radiofrequency (RF) fields greater than a whole-body-averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes at 3-Tesla in a patient with the RELAY® stent-graft.

• Safety information for magnetic resonance imaging (MRI) procedures pertains to the use of MR systems with static magnetic fields of 3-Tesla or less (maximum spatial gradient 3.3-Tesla/m) and a whole body averaged specific absorption rate (SAR) of 2.0W/kg for 15 minutes of MR imaging. The effects of performing MRI procedures using MR systems with static magnetic fields greater than 3-Tesla and other conditions have not been determined.

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ThoracicAorta Proximal

Vessel Size(mm)

Stent-graft Size

(mm)

Percent ofStent-graft

Oversize (%)

Outer Primary Sheath French Size (O.D.) (3 FR = 1 mm)

100mmStent-graft

(FR)

150mmStent-graft

(FR)

200mmStent-graft

(FR)

250mmStent-graft

(FR)

Stent-graft Diameter Proximal Length

22-28 mm30-38 mm40-46 mm

15 mm20 mm25 mm

Fever

Post Implantation Syndrome

Hematoma

Blood Loss

Hemorrhage

Infection

Cardiac events

Anaphylaxsis

Vessel Dissection

Vessel Occlusion/Thrombosis

Vessel Damage

Emboli

Hepatic failure

Ischemia (spinal cord, perfusion pathways)

Renal failure or Complications

Aneurysm / Lesion Rupture

Arteriovenous fistula / aorto-esophageal fistula

Radiation overexposure or reaction

Pseudoaneurysm

Transient ischemic Attack

Cerebral vascular accident (stroke)

Congestive heart failure

Paralysis/Paresthesia/Paraparesis

Death

Incision Site Complications

Limb ischemia

Delivery system failure

Access failure

Stent graft misplacement

Endoleak

Stent graft migration

Stent graft failure

Wire form fractures

Suture fracture

Deployment failure

Perforation

Device dehiscence

Stent-graft tearing/wear

ProductID

28

DeviceType

DesignModification

Number

StentDiameterProximal

StentCoveredLength

StentDiameter

Distal

DeliverySystem

French Size

DeliverySystemusableLength

DeviceDesignation

M: Main 3 XX XXX XX XX XX S: StandardCatalog Product

28x2430x2632x2834x3036x3238x3440x3642x3844x4046x42

Stent-graft Covered Length

150mmStent-Graft

24-2525-2728-2930-3132-33

3435-3637-3839-4041-42

20-2122-2324-2526-2728-2930-3132-33

3435-3637-38

12-1711-1510-149-139-1211

11-1410-1310-139-12

14-2013-1812-1711-1510-149-139-1211

11-1410-13

164164164154154154154159164164

204209209209199199204204209209

259259259259259259259259259259

22222323242425252526

22232324242525252526

23232424252525252626

200mmStent-Graft

250mmStent-Graft

150mmStent-Graft(FR)

200mmStent-Graft(FR)

250mmStent-Graft(FR)

Outer Primary SheathFrench Size (O.D.)

ThoracicTaperStent-

Graft Size(mm)

Proximal Distal Proximal Distal

Thoracic VesselSize (mm)

Percent of Stent-Graft Oversize (%)

Stent-graft Diameter Distal Length

22-28 mm40-46 mm

15 mm25 mm

EN

G

ADVERSE EVENTS

Adverse events that may occur in conjunction with endovascular procedures include, but are not limited to those listed in the following section.

- In the event of surgical removal or post-mortem examination, please contact Bolton Medical for guidance on removal and disposal of implant.

SYMBOLS/DEFINITIONS

MANUFACTURER: LOCATION:

BOLTON MEDICAL ESPAÑA, S.L.U.C/NEWTON, 18 - 2408635 SANT ESTEVE SESROVIRESBARCELONA, SPAINTELEPHONE: +34-93-817-63-23FACSIMILE: +34-93-817-63-08

BOLTON MEDICAL, INC799 INTERNATIONAL PARKWAYSUNRISE, FLORIDA 33325 USATELEPHONE: +1 954 838-9699FACSIMILE: +1 954 838-8224

Do not Re-use

Do not Re-Sterilize

Model/Catalogue Number

Use By

Caution

MR Conditional

Consult Instructions for use

Date of Manufacture

Manufacturer

Lot Number

Store in a cool, dry placeDo not use if package is damaged

Sterilized by Irradiation