How Supplied - COOK Medical Zilver Flex 35 Mode D'emploi

4. Hold the hub end stationary. The stent will be deployed as you pull the handle (a) toward
the hub (b). (Fig. 3) The radiopaque marker on the delivery system (h) indicates the
progress of the deployment. NOTE: Full deployment of the stent length will occur when
the distal end of the sheath has been retracted past the proximal part of the stent.
5. As deployment occurs, continue sliding the handle (a) toward the hub (b) in a slow,
smooth and consistent fashion. (Fig. 4) NOTE: Once stent deployment has begun, the
stent must be fully deployed. Repositioning of the ZILVER FLEX™35 Vascular Stent
is not possible since the delivery system's outer sheath cannot be readvanced over
the stent once deployment begins. Refer to the Multiple Stent Placement section of
these instructions for use for information on missed lesions.
6. The stent is fully deployed when the handle (a) reaches the hub (b). (Fig. 5)
7. Perform an arterial angiogram to ensure proper placement of the device. NOTE: If
incomplete expansion exists within the stent at any point along the lesion, post-
deployment balloon dilatation (standard PTA) can be performed at the discretion of
the physician. Select an appropriate size PTA balloon catheter and dilate the lesion with
conventional technique. The inflation diameter of the PTA balloon used for post dilatation
should approximate the diameter of the reference vessel. Remove the PTA balloon from
the patient.
8. Delivery System Removal - Do not advance sheath after the stent has been deployed.
Delivery System can be removed without recapturing tip. Check for delivery system
integrity post removal from the patient.
9. Introducer sheath and wire guide may be removed at this point.
Multiple Stent Placement
If placement of more than one stent is required, the following recommendations should be
considered:
• When more than one stent is required, resulting in stent-to-stent contact, stent
materials should be of similar composition to avoid the possibility of dissimilar metal
corrosion.
• In relation to the lesion site, the distal area of narrowing should be stented first,
followed by the proximal locations (i.e., a second stent should be placed proximal to the
previously placed stent).
• Stents placed in tandem should slightly overlap.

HOW SUPPLIED

Supplied sterile by ethylene oxide gas in peel-open packages. Intended for one-time use.
Sterile if package is unopened or undamaged. Do not use the product if there is doubt as
to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure
to light. Upon removal from the package, inspect the product to ensure no damage has
occurred.
Upon completion of procedure, dispose of components per institutional guidelines for
biohazardous medical waste.
REFERENCES
These instructions for use are based on experience from physicians and (or) their published
literature. Refer to your local Cook sales representative for information on available literature.
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