The GORE® Tri-Lobe Balloon Catheter is engineered to facilitate endovascular procedures through several key features:

• Device Stability: Reduced endoprosthesis movement during positioning
• Continuous Blood Flow: Our unique tri-lobe design allows continuous blood flow around the lobes while inflated
• Compliant Construction: Compliant polyurethane balloons offer exceptional conformance to the endoprosthesis
• Greater Control: Rapid, uniform, and simultaneous balloon lobe inflation/deflation minimizes potential blood pressure spikes by not occluding the aorta when balloons are fully inflated.

The GORE® Tri-Lobe Balloon Catheter provides surgeons with higher degree of control in positioning endovascular grafts. Our innovative device is available in two sizes compatible with 18 Fr introducer sheaths. The small size is designed for 16–32 mm vessel diameters (for use with the Conformable GORE® TAG® Thoracic Endoprosthesis or the GORE® EXCLUDER® AAA Endoprosthesis). The large size is designed for 26–42 mm vessel diameters (for use with the Conformable GORE® TAG® Thoracic Endoprosthesis).

The GORE® Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

WARNINGS

• Excessive inflation volume may result in balloon rupture, embolization, vessel damage, vessel rupture, or patient death. • Do not continue if resistance is felt during advancement or retraction of the balloon catheter. Stop and assess the cause of the resistance. Continued movement against resistance may result in prosthesis migration, vessel damage, and / or catheter damage. • Do not advance or retract the balloon catheter while the balloons are inflated. Ensure the balloons are deflated using fluoroscopy before moving the balloon catheter. • Do not inflate the balloons in areas of significant calcified plaque. Balloon rupture and / or vessel damage may occur. • Do not use in the ascending aorta as W. L. Gore & Associates, Inc. (Gore) has insufficient information to support this application. • If the deflated balloon catheter gets caught on the leading edge of the introducer sheath during retraction, carefully push the balloon catheter slightly forward, while keeping the introducer sheath stationary, and rotate the balloon catheter. Carefully try to retract the balloon catheter into the introducer sheath. Alternative methods are to pull the guidewire back until the guidewire tip is well inside the balloon catheter and / or to pull the introducer sheath back slightly until the tip of the sheath is in a straighter section of the vessel. At this point, try retracting the balloon catheter from the sheath. If resistance is still felt, remove the balloon catheter and the introducer sheath together. • Incorrect usage of the balloon catheter may result in prosthesis movement and may require additional prosthesis placement or surgical intervention. • Observe inflation and deflation of the balloons under fluoroscopy to ensure proper functioning of the balloon catheter. Withdrawal of the balloon catheter prior to deflation may result in prosthesis migration, vessel damage, and / or catheter damage. • Do not use high pressure injector.

PRECAUTIONS

• The GORE® Medical Device is designed for single use only; do not reuse device. Gore does not have data regarding reuse of this device. Reuse may cause device failure or procedural complications including device damage, compromised device biocompatibility, and device contamination. Reuse may result in infection, serious injury, or patient death. • Do not resterilize. • Do not use after the labeled "use by" (expiration) date. • Do not use device if damaged or if sterile barrier has been compromised.

Adverse events which may require intervention include, but are not limited to: fever; infection; hemorrhage or bleeding at the site of catheter introduction; hematoma; lymph fistula; local neurologic damage; arteriovenous fistula; pseudoaneurysm; thrombosis; embolization; trauma to the vessel wall, including spasm, dissection, perforation or rupture; renal insufficiency or failure; allergic reaction to contrast media; respiratory complications; stroke; arrhythmia; myocardial infarction; prosthesis movement or occlusion; aneurysm rupture and death.