Medtronic REL46 Instructions for Use

Reliant™

Stent Graft Balloon Catheter

Instructions for Use

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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Reliant™

Explanation of symbols that may appear on product labeling

Refer to the device labeling to see which symbols apply to this product.

Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union acts.

Do not use if package is damaged

Minimum sheath inner diameter

Do not re-use

Lot number

Authorized representative in the European Community

Catalog number

Use by date

Manufactured in

Sterilized using ethylene oxide

Inflated balloon diameter

Consult instructions for use at this website

Inflation volume maximum

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Caution

Quantity

Date of manufacture

Manufacturer

Nonpyrogenic

Peel tab to open

Do not resterilize

1 Device description

The Reliant stent graft balloon catheter is designed to assist in the expansion of self-expanding stent grafts used for the treatment of abdominal aortic aneurysms (AAA) and thoracic aortic aneurysms (TAA). Ballooning of a stent graft may improve modeling of the graft material and fixation of the stent graft to the vessel wall. Suboptimal expansion of self-expanding stent grafts may also be improved by inflating the balloon at the site of the stent.

Note: Read the entire Reliant stent graft balloon catheter Instructions for Use prior to performing a ballooning procedure.

Warning: Only physicians and teams trained in vascular surgery, interventional radiology, or cardiology, and who have completed

training or have experience with stent grafts and balloon catheters should consider using this device.

Figure 1. Reliant Stent Graft Balloon Catheter

1 Extension with 3-Way Stopcock 2 Y-Connector 3 Strain Relief 4 Guidewire Lumen

The Reliant stent graft balloon catheter consists of the following components:

• multi-lumen placement catheter

• compliant polyurethane balloon

• radiopaque marker bands

• strain relief

• extension with 3-way stopcock

• Y-Connector (backend hub)

The Reliant stent graft balloon catheter has a compliant polyurethane balloon with a maximum diameter of 46 mm. The usable length for this device is 100 cm. This device is designed to accommodate a 0.97 mm (0.038 in) diameter or smaller guidewire. Two radiopaque marker bands are placed within the balloon to facilitate balloon placement, prior to inflation.

5 Balloon Marker Bands 6 Catheter 7 Balloon

2 Intended Use

The Reliant stent graft balloon catheter is intended to temporarily occlude large vessels or to expand vascular prostheses.

The device is intended to assist in the expansion of self-expanding stent grafts.

3 Contraindications

The Reliant stent graft balloon catheter is contraindicated in patients who:

• are contraindicated to contrast media or anticoagulants

• have an arterial entry site that cannot accommodate a 12 Fr (4 mm) introducer

• are less than 18 years old

• are pregnant or nursing

4 Warnings and precautions

Caution: Federal (USA) law restricts this device to sale by or on order of a physician.

• Preparations should be made and a trained vascular surgical team available in the event that conversion to open surgery is required.

• Carefully monitor the patient’s blood pressure throughout the procedure.

• If an obstruction in the vessel (eg, a tortuous bend, stenosis, calcification) prevents advancement of the catheter, use standard techniques to dilate or straighten the vessel before continuing to advance the catheter.

• Balloon rupture may occur under certain anatomical, procedural, or clinical circumstances so it is recommended that backup Reliant stent graft balloon catheters are available.

• Do not overinflate the balloon when modeling graft in vessels. Operator should visualize the stent graft at all times during balloon inflation to detect any stent graft movement.

• The Reliant stent graft balloon catheter is not intended for use as an angioplasty balloon.

• Do not use Reliant stent graft balloon catheter for more than 20 inflation or deflation cycles.

• If the proximal and distal radiopaque markers of the Reliant device are not completely within the covered stent graft,

there is an increased risk of vessel injury, rupture, or possible patient death.

• The device is not for use in endovascular prostheses contraindicated for use with compliant balloon catheters.

• Do not use the Reliant stent graft balloon catheter in treatment of aortic dissection disease.

• Do not reuse or resterilize – This device is for single use only. This device is intended to contact body tissues. Do not reuse, reprocess, or resterilize. Reprocessing may compromise the structural integrity of this device. Reuse of this device creates a potential risk of patient infections due to contamination. This contamination of the device may lead to injury, illness, or death of the patient. Do not use if the package is damaged or opened outside a sterile field. After use, dispose of the device according to the prevailing hospital, administrative, or local governmental regulations.

• Increased manipulation or duration of the procedure may lead to microembolization.

• Do not exceed the maximum inflation diameter (46 mm) because the balloon could rupture.

• Overinflation of a balloon can cause damage to the vessel wall or stent graft, which can lead to vessel rupture. Care should be taken when inflating a balloon in vessel, particularly when inflating in the distal-most spring, calcified, stenotic, or otherwise diseased vessels.

• Not for use in the heart or coronary arteries.

• Do not use a high-pressure injector with the Reliant stent graft balloon catheter. Hand injections are recommended.

• Do not use a power injector for injection of contrast medium through the distal catheter lumen because rupture may occur.

• Medtronic is not responsible for mis-sizing, misuse, or misplacement of the device.

5 Potential Complications and Adverse Events

Complications may occur with any stent graft balloon catheterization procedure. Therefore, only physicians trained in vascular surgery, interventional radiology, or cardiology, and who have completed training or have experience with stent grafts and balloon catheters should consider using this device. Possible complications associated with this type of procedure include, but are not limited to:

Clinically Related:

• vessel perforation or dissection • respiratory failure

• paresthesia • general malaise

• entry site infection • emboli

• entry site hematoma • hemorrhage

• stroke • renal complications

• aneurysm rupture • death

• cardiac events

Device Related:

• balloon catching inside of graft during catheter movement • inability to inflate/deflate balloon

• stent graft migration caused by balloon catheter device • inability to insert guidewire

• balloon rupture

6 Patient Counseling

There are risks involved with any medical procedure. Both physician and patient should fully understand the risks and benefits associated with this endovascular device and procedure.

7 How supplied

The device is sterilized using ethylene oxide.

8 Additional equipment recommended

• diluted contrast (75% sodium chloride/25% renographin) for balloon inflation or deflation

• Heparinized saline solution

• backup Reliant stent graft balloon catheters

• freely-angled c-arm with: – high resolution fluoroscopy – high quality angiography – digital subtraction angiography (DSA)

• surgical suite standby, in the event that emergency surgery is necessary

• inventory of introducer sheaths/dilators, syringes, and guidewires

9 Procedural Instructions

In accordance with standard technique, it is recommended that patients be anticoagulated during the procedure.

9.1 Preparation

Note: Entry site preparation to be performed prior to device preparation.

1. Attach syringe to guidewire lumen.

2. Use the syringe to flush the guidewire lumen with heparinized saline solution.

3. Remove the syringe from the guidewire lumen and connect it to the opened stopcock on balloon lumen. Draw a vacuum in the balloon and close stopcock.

4. Gently remove the protective sleeve from the balloon.

5. Fill syringe with heparinized saline solution and open stopcock.

6. Hold catheter with distal tip and balloon pointing down.

7. Partially inflate balloon.

8. Draw back on the syringe to deflate the balloon.

9. Repeat step 7 and step 8. Each time this is repeated, more volume of air is displaced with liquid. Attempt to remove all of the air in the balloon. Some changes in the catheter orientation may be necessary to vent all the air.

10. Draw a vacuum in the balloon and close stopcock.

11. Insert guidewire and advance it beyond the stent graft.

12. Place 12 Fr (4 mm) introducer/dilator in the femoral artery, over the guidewire.

13. Remove dilator from introducer.

9.2 Introduction

1. Verify that the balloon is deflated.

2. Slowly insert the Reliant stent graft balloon catheter over the guidewire. Caution: When aligning the position of the catheter so that the balloon is in the proper position for expansion within the vessel,

pay careful attention to the fluoroscope location to avoid parallax or other sources of visualization error.

9.3 Confirm position

Use fluoroscopy and angiography to ensure that the balloon is at the target expansion site. Radiopaque markers located near the bonds of the balloon should be placed just proximal and distal of the target location.

9.4 Balloon Inflation/Deflation

1. When the Reliant stent graft balloon catheter is positioned properly, it may be appropriate to decrease the patient’s blood pressure to approximately 80 mmHg to facilitate ballooning.

Caution: Failure to lower the blood pressure during thoracic cases may cause balloon movement and may result in stent graft misplacement.

2. Inflate the balloon to expand the target location. Continuously monitor fluoroscope screen, watching for stent movement. Proper modeling should show very slight outward expansion of stent with balloon inflation. Do not overinflate. Stop after stent graft expansion is evident. The table below is a guideline for determining the volume of solution (75% sodium chloride/25% renographin) required to obtain a given balloon expansion diameter:

46 mm Balloon

Diameter mL (cc)

10 mm 3 20 mm 9 30 mm 19 40 mm 41 46 mm 60

Caution: This chart is only a guide. Balloon expansion should be carefully monitored with the use of fluoroscopy. Caution: Do not exceed the maximum inflation diameter (46 mm) because the balloon could rupture. Overinflation can also

cause damage to the vessel wall or stent graft or lead to vessel rupture. Note: The balloon has been tested to temporarily occlude vessels up to 37 mm in diameter.

3. Fully deflate balloon and then verify it is deflated.

4. Move the balloon distally; inflate and deflate it to smooth wrinkles in the stent graft material and to enhance contact between the stent graft and vessel wall.

Warning: Ensure the balloon is fully deflated before moving the Reliant stent graft balloon catheter.

5. Repeat until all target areas of the stent graft have been modeled. Inflate the balloon in the distal spring area with sufficient pressure to firmly embed the spring against the vessel.

Caution: Balloon is highly compliant. Inflate slowly and do not overexpand. Use special care in areas of diseased vessels to avoid rupture or vessel trauma

9.5 Remove Catheter and Seal Entry Site

1. Draw a vacuum in the balloon. Verify that the balloon is fully deflated.

2. Withdraw the Reliant stent graft balloon catheter back through the introducer sheath.

3. Gently remove the Reliant stent graft balloon catheter and guidewire. Use fluoroscopy to ensure that the stent graft does not move and to track the movement of the Reliant stent graft balloon catheter throughout the withdrawal.

Note: Close entry site with standard surgical closure technique.

10 Disclaimer of warranty

The warnings contained in the product labeling provide more detailed information and are considered an integral part of this disclaimer of warranty. Although the product has been manufactured under carefully controlled conditions, Medtronic has no control over the conditions under which this product is used. Medtronic, therefore, disclaims all warranties, both express and implied, with respect to the product, including, but not limited to, any implied warranty of merchantability or fitness for a particular purpose. Medtronic shall not be liable to any person or entity for any medical expenses or any direct, incidental, or consequential damages caused by any use, defect, failure, or malfunction of the product, whether a claim for such damages is based upon warranty, contract, tort, or otherwise. No person has any authority to bind Medtronic to any representation or warranty with respect to the product.

The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. If any part or term of this disclaimer of warranty is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of this disclaimer of warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this disclaimer of warranty did not contain the particular part or term held to be invalid.

Medtronic, Inc.

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710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000 LifeLine Technical Support, 24-hour consultation service: 1 877 526 7890