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BAWB05663.qxp
09.07.2007
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Placement in the distal superficial femoral artery
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Placement in the popliteal artery
Warnings:
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This product has been designed for single patient use only. Do not reuse. Do not resterilize.
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The sterile packaging and devices should be inspected prior to use. Verify that the packaging and the device are undamaged and that the sterile
barrier is intact. If damaged, do not use.
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The delivery catheter is not intended for any use except stent graft deployment.
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Placing a stent graft across a side branch may impede blood flow and prevent or hinder future access or other procedures.
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The stent graft (implant) cannot be repositioned within the artery after total or partial deployment.
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Once partially or fully deployed, the FLUENCY* Plus Vascular Stent Graft cannot be retracted or remounted onto the delivery system.
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An appropriate guide wire is required before introduction of the stent graft delivery system into the body. The guide wire must remain in place
during the introduction, manipulation and eventual removal of the deployment system.
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After use, the FLUENCY* Plus Vascular Stent Graft deployment system is a potential biohazard. Handle and dispose of in accordance with accepted
medical practice and with applicable local, state and federal laws and regulations.
Precautions:
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This device should be used only by physicians who are familiar with the complications, side effects, and hazards commonly associated with intravascular
stent graft procedures.
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Faulty placement techniques may lead to failure in stent graft deployment.
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Do not kink the delivery catheter. Ensure that the Tuohy-Borst valve on the Y-injection-adapter is closed during insertion and overall manipulation
of the delivery system. The Tuohy-Borst valve must remain closed until the stent graft is positioned at the final intended location and about to be
released.
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Prior to stent graft deployment in tortuous anatomy, ensure that the proximal stent graft end is positioned in a straight section of the lumen to
reduce the risk of increased deployment forces and possible failure to deploy.
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The delivery system can function only after the safety clip is removed and the Tuohy-Borst valve is loosened. This should not be done until the
stent graft is about to be released.
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Higher deployment force may be encountered on longer length stent graft.
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Careful attention of the operator is warranted to mitigate the potential for distal migration of the endoprosthesis during deployment.
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Do not attempt to resheath the deployment system after stent graft release.
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The FLUENCY* Plus Vascular Stent Graft cannot be balloon expanded beyond its stated diameter.
Note:
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Read all instructions for use thoroughly.
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Predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician.
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The use of a superstiff guidewire is recommended for stent graft placement.
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Both female Luer-lock ports must be flushed with sterile saline before introduction of the delivery system.
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Stent graft expansion begins, after the Y-injection-adapter moves approximately 20-30 mm towards the handgrip.
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Post dilatation of the implanted stent graft is required with a balloon equal in diameter to that of the selected stent graft diameter.
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Post stent graft anticoagulation and prophylactic antibiotic therapy should be prescribed at the physician's discretion. According to published
clinical literature about similar self-expanding stent grafts, the prophylactic inhibition of platelet aggregation should be considered.
Potential Complications:
All complications that have been reported in association with conventional vascular stents and stent grafts may also occur during or after insertion of
a FLUENCY* Plus Vascular Stent Graft. These include bleeding at the site of catheter placement, infection, fever, pain, thrombosis, pseudoaneurysm,
arteriovenous fistula, abscess, distal embolization, trauma to the vessel wall, vessel rupture, dissection, stent graft misplacement, stent graft migration,
early stent graft occlusion and restenosis.
Stent Graft Sizing and Selection:
Special care must be taken to ensure that the appropriate size FLUENCY* Plus Vascular Stent Graft is selected prior to introduction.
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In order to ensure adequate wall apposition, slight oversizing of the stent graft with reference to the lumen diameter is recommended. Oversizing
of the stent graft of more than 2 mm relative to the lumen diameter should be avoided. Please see table below:
Labelled Stent Graft
Diameter (mm)
Recommended oversizing
with reference to lumen
diameter (mm)
15:57
Seite 6
5 mm
6 mm
7 mm
0.5 mm – 1 mm
6
8 mm
9 mm
10 mm
1 mm – 2 mm
12 mm
13.5 mm
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