English; Information For Use - Bard FLUENCY PLUS Instructions D'utilisation

BAWB05663.qxp 09.07.2007

English

INFORMATION FOR USE

Please review the gatefold at the end of the booklet! The step-by-step illustrations will help you to better understand the directions for use.
Device Description (see diagram and illustrations on page 2 of this booklet)
The FLUENCY* Plus Vascular Stent Graft (implant) is a self-expanding Nitinol Stent encapsulated with ePTFE (expanded Polytetrafluoroethylene) (A).
There are four radiopaque PUZZLE* Tantalum Markers (B) on each end of the Nitinol stent, facilitating stent graft placement by enhancing visibility
under fluoroscopy. The Nitinol stent is encapsulated with ePTFE along the entire length, except the flared stent graft ends with the radiopaque tantalum
markers. The length of the uncovered portion of the stent graft is approximately 2 mm at each end (C), NOT including the radiopaque tantalum markers.
The FLUENCY* Plus Vascular Stent Graft is available in various diameters and lengths.
The stent graft (A) is supplied premounted between the inner catheter (D) and the outer sheath (E) on the distal section of the delivery system. In this
compressed configuration, the Nitinol stent struts lie close together and the radiopaque tantalum markers appear as a contiguous band at each end of
the stent graft.
The flexible delivery system is a coaxial catheter system consisting of an inner catheter (D), which connects to the handgrip (F) via a metal tube and
a coaxial outer sheath (E), which connects to a Y-injection-adapter (G) with a Tuohy-Borst valve (H).
Using the BARD S.A.F.E.* Delivery System technology, the soft and flexible catheter tip is formed from the outer catheter sheath. The catheter tip is
tapered to accommodate a 0.035 in. guide wire.
Tightening the Tuohy-Borst valve (by turning it clockwise) prevents movement of the outer sheath relative to the inner catheter. There is also a removable
safety clip (I) that prevents premature outer sheath retraction. The safety clip can be removed by pressing down on the top of the clip. In order to deploy
the stent graft, the Tuohy-Borst valve must be open and the safety clip must be removed.
The delivery system has two female Luer-lock ports: one (K) at the proximal end of the handgrip, and the second (L) on top of the Y-injection-adapter.
Prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped
in the inner catheter lumen and/or the stent graft lumen. Flushing these lumens will also facilitate stent graft deployment. When flushing the stent graft
lumen via the top port, ensure that the 2-way stopcock (M) is open, and that the Tuohy-Borst valve is closed.
There is a radiopaque marker band (N) on the outer sheath of the delivery system. Before stent graft deployment, this marker band overlaps the highly
radiopaque tantalum markers. During stent graft deployment the marker band will retract (towards the handgrip). When the moving marker band is past
the proximal stent graft end for approximately 10 mm, the stent graft is fully released. Furthermore, the radiopaque tantalum markers on the proximal
end of the stent graft will have visually separated when the stent graft is fully released.
How Supplied:
The FLUENCY* Plus Vascular Stent Graft is supplied sterile (by ethylene oxide gas) unless the package has been opened or damaged. For single use
only. Do not reuse. Do not resterilize. Store in a cool (room temperature), dry place. Protect the packaged product from direct exposure to sunlight.
Indications for Use:
• Residual stenosis with impaired perfusion (pressure gradient) following balloon dilatation, especially in stages III and IV according to Fontaine
• Dissection
• Detached arteriosclerotic plaque material and luminal obstruction following balloon dilatation
• Occlusion after thrombolysis or after aspiration and before dilatation
• Restenosis or reocclusion
Contraindications:
• Uncorrected coagulopathies
• Functionally relevant obstruction of the inflow path, poor outflow or no distal runoff
• Fresh, soft thrombotic or embolic material
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FLUENCY* PLUS Vascular Stent Graft
5
with PUZZLE* Tantalum Markers
and BARD S.A.F.E.* Delivery System