Patient Preparation - COOK Medical Evolution EVO-20-25-8-E Instructions For Use Manual

For US Patients Only
Cook recommends that the patient register the MR conditions disclosed
in this IFU with the MedicAlert Foundation. The MedicAlert Foundation
can be contacted in the following manners:
Mail: MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
Phone: 888-633-4298 (toll free)
209-668-3333 from outside the US
Fax: 209-669-2450
Web: www.medicalert.org
EQUIPMENT REQUIRED
Stent and delivery system
.035 inch wire guide
SELECTION OF STENT
A stent length of at least 4 cm longer than the stricture is recommended
(e.g. approximately 2 cm longer at either end of the stricture)

PATIENT PREPARATION

1. Place wire guide through the stricture.
INSTRUCTIONS FOR USE
1. Remove protective tubing from stent.
2. Introduce delivery system in short increments over wire guide, into
accessory channel, until it is endoscopically visualized exiting the scope.
3. To ensure that stent will bridge stricture after deployment,
fluoroscopically position radiopaque markers on inner catheter beyond
extremities of stricture to be crossed. Note: yellow marker on the
delivery system located at proximal end of stent can also serve as a
endoscopic/fluoroscopic reference for positioning of the proximal
(nearest user) end of the stent relative to the stricture.
4. Confirm desired stent position fluoroscopically and deploy stent by
removing red safety guard from the handle. (See Fig. 1)
9
Illustrations