Bard FLUENCY PLUS Instructions D'utilisation page 7

BAWB05663.qxp 09.07.2007
• If a stent graft is oversized per the above table, there is minimal foreshortening of the stent graft during deployment; therefore, the length of the
compressed stent graft is virtually equivalent to the expanded stent graft length. Depending on the stent graft size, the length of the stent graft
can vary from the labelled length up to 5 mm. In order to ensure safe stent graft placement and lesion coverage, we recommend the use of a
stent graft that is long enough to extend a minimum of 10 mm beyond the lesion/stenosis at both ends. When selecting the stent graft length,
keep in mind that 2 mm of the stent graft are uncovered at each end.
Directions 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.
Preparation:
1. Carefully remove the delivery system from its packaging and inspect for any damage or defects. Do not use if a compromise to the sterile barrier
is suspected.
2. A super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site. Use an introducer sheath for the implant procedure.
Note: Predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician.
3. Tighten the Tuohy-Borst valve on the Y-injection-adapter by turning it clockwise. (see figure 1)
4. Flush the stent graft lumen with sterile saline using a small volume (e.g., 3-cc) syringe. Attach the syringe to the Luer-lock port of the Y-injection-
adapter on top of the delivery system and apply positive pressure. Ensure that the 2-way stopcock is open. Continue until saline drips from the
distal end of the delivery system. Close the stopcock when flushing is complete. (see figure 2)
5. Also flush saline through the inner catheter lumen via the Luer-lock port at the back of the delivery system. A larger volume syringe may be used.
Flush until saline leaks from the tip of the catheter and all air is removed. (see figure 2)
Introduction of the delivery system:
6. Under radiographic guidance, advance the stent graft across the lesion. Use the radiopaque stent graft ends to center the stent graft across the
lesion. (see figures 3 and 4)
It is recommended to advance the delivery system past the lesion and then pull back slightly on the entire system to attain correct positioning of
the radiopaque markers and to ensure the delivery catheter is straight.
7. Confirm the exact position of the radiopaque tantalum markers on the stent graft ends. It is recommended that the position of the stent graft ends
(1) and (2, 3) be marked on the monitor or that radiopaque skin markers be placed as reference points for stent graft ends. (see figure 5)
Stent Graft Deployment:
8. When the stent graft is about to be released, open the Tuohy-Borst valve, then remove the safety clip by pressing down on the top of the grip surface
with the thumb, then pulling downward. (see figure 6)
9. Confirm that the positions of both radiopaque stent graft ends still correspond to the lesion location, then slowly pull back the Y-injection-adapter.
Pulling the Y-injection-adapter back towards the handgrip directly retracts the outer sheath and exposes a corresponding portion of the stent graft.
(see figure 7) Higher deployment force may be encountered with longer length stent grafts.
Note: The radiopaque tantalum markers on the stent graft ends (1) and (2) must not move laterally during stent graft deployment.
The radiopaque marker band on the outer catheter (3) moves backwards during stent graft release. (see figure 8)
Note: Stent graft expansion begins, after the Y-injection-adapter moves approximately 20-30 mm towards the handgrip.
10. During release of the stent graft, the entire length of the flexible deployment system should be kept as straight as possible. A slight back tension
on the handgrip is recommended to ensure that the deployment system is stationary and straight.
Note: Do not hold or kink the outer sheath of the delivery catheter since it must be free to move during deployment. (see figure 9)
11. Ensure that only the Y-injection-adapter and outer sheath move during stent graft deployment, and the handgrip is kept stationary.
12. Pull back on the Y-injection-adapter slowly until the stent graft has expanded by approximately 15 mm, then wait a few seconds in order to ensure
secure "anchoring" of the distal stent graft end. Once anchored, the remainder of the stent graft can be released slowly.
Full release of the stent graft is achieved when the Tuohy-Borst valve touches the handgrip (see figure 10). Furthermore, the radiopaque tantalum
markers on the proximal end of the stent graft will have visually separated when the stent graft is fully released.
13. Remove the flexible deployment system over the guide wire. Do not attempt to resheath the deployment system after stent graft release.
15:57 Seite 7
7