COOK Medical Zilver Flex 35 Mode D'emploi page 12

• Spasm
• Tissue necrosis
• Worsened claudication/rest pain
PRODUCT RECOMMENDATIONS
Arterial access
For arterial access, we recommend the use of an access set that accepts a 6.0 French (2.0mm)
introducer catheter.
Wire Guide Selection
The use of a .035-inch (0.89mm) wire guide is recommended.
PTA Balloon Selection
For pre- and post-dilation, an appropriately sized balloon catheter is recommended.
Stent Selection
The chosen stent diameter should be at least 1 mm larger than the diameter of the reference
vessel.
PROCEDURE
Access
1. Gain access at the appropriate site utilizing an introducer sheath or guiding catheter.
Refer to product labeling for required introducer sheath or guiding catheter size.
2. Introduce the extra or ultra stiff .035" (0.89mm) wire guide through the introducer sheath
or guiding catheter across the distal segment of the target lesion.
3. Predilate if necessary. Remove the balloon catheter, leaving the wire guide in place.
4. Determine the proper stent size after complete diagnostic evaluation. The stent diameter
should be at least 1 mm larger than the diameter of the reference vessel. Measure the
length of the target lesion to determine the length of the stent required. Allow for the
proximal and distal aspects of the stent to cover the entire target area. NOTE: If multiple
stents are required to cover the length of the lesion, please refer to the Multiple Stent
Placement section of these instructions for use for further recommendations.
5. Use the 1 ml syringe to flush the wire guide lumen with saline through the hub.
6. Immediately before placing the delivery system into the body, use a 1 ml syringe to flush
the delivery system with saline through the side-arm flushing port. Flush until a few
drops of saline exit the distal tip, between the delivery system outer sheath (d) and inner
catheter (e).
7. Insert the delivery system over the wire guide.
8. Under fluoroscopy, advance the delivery system past the lesion.
9. Pull back on the stent delivery system under fluoroscopy until the radiopaque markers on
the stent (i) are at the desired position. The stent is now ready to be deployed. (Fig. 1)
Deployment of the Stent
1. Before deployment, it is important to straighten the proximal part of the delivery system
as much as possible and to keep the handle in a stable position.
2. The stent expansion must be performed under fluoroscopic control.
3. Hold the hub (b) on the metal cannula (g) steady. To deploy the stent, remove the red
safety lock (c). (Fig. 2)
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Illustrations