GORE Tri-Lobe Mode D'emploi page 4

• 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
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.
CONTENTS / HOW SUPPLIED
The GORE® Tri-Lobe Balloon Catheter is supplied sterile and non-pyrogenic.
STORAGE AND HANDLING
Store in a cool dry place.
REQUIRED MATERIALS
• 60 cc or smaller syringe
• Heparinized saline
• 0.035" (0.89 mm) guidewire, 250 cm or longer
• 18 Fr or larger introducer sheath
• Radiopaque contrast media
• 3-way stopcock
DIRECTIONS FOR USE
Balloon Catheter Preparation
1. Remove the GORE® Tri-Lobe Balloon Catheter from its packaging and examine for possible damage.
2. Open the Tuohy-Borst valve on the flushing / guidewire port. Flush heparinized saline through the guidewire lumen.
3. Attach a 3-way stopcock to the inflation port.
4. Fill a 60 cc or smaller syringe with 30:70 radiopaque contrast media to saline solution (diluted contrast solution) and attach
to the stopcock of the inflation port.
5. Orient the balloon catheter with the tip downward. Aspirate air from the balloons and shaft using the syringe. Next, partially
inflate the balloons with diluted contrast solution. Repeat aspiration and inflation until all of the air has been evacuated
from the balloons.
6. Inflate the balloon catheter with 15 cc of diluted contrast solution. Inspect the balloon catheter for the formation of three
lobes and for the presence of leaks.
NOTE: If three lobes are not formed or if balloon catheter leakage is noted during inflation, do not use balloon catheter.
7. Draw a vacuum on the balloon catheter and close the stopcock to maintain the vacuum on the balloon catheter.
Balloon Catheter Inflation(s)
1. Maintaining a vacuum on the balloon catheter, advance the balloon catheter over a 0.035" (0.89 mm) guidewire, through an
18 Fr or larger introducer sheath.
2. Using fluoroscopic guidance, position the balloon catheter using the radiopaque markers.
3. The volume of diluted contrast solution used to inflate the balloon catheter will determine the balloon diameter achieved
(Figure 2). Observe inflation of the balloons under fluoroscopy to determine if additional inflation volume is required to
optimize balloon contact. To avoid vessel trauma, do not over-inflate the balloons in relation to the diameter of the artery or
other devices.
4. Deflate the balloon catheter, rotate the balloon catheter approximately 60º and repeat the inflation.
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