COOK Medical Evolution Instructions For Use Manual page 3

ENGLISH
Evolution™ Esophageal Stent System – Partially Covered / Fully Covered
IMPORTANT INFORMATION
Please review prior to use.
INTENDED USE
This device is used to maintain patency of malignant esophageal strictures and/or to seal
tracheoesophageal fistulas.
STENT DESCRIPTION
This flexible, self-expanding stent is constructed of a single, woven, nitinol wire. The stent
foreshortens due to its design. The total length of the stent is indicated by radiopaque
markers on the inner catheter, indicating the actual length of the stent at nominal stent
diameter. There is a lasso at the proximal end of the stent (partially covered) or the proximal
and distal ends of the stent (fully covered), purpose is to reposition the stent in the event of
incorrect placement.
DELIVERY SYSTEM DESCRIPTION
Stent is mounted on an inner catheter, which accepts a .035 inch wire guide, and is
constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or
recapture.
NOTES
Do not use this device for any purpose other than stated intended use.
Part numbers with the prefix EVO-FC are Fully Covered.
If package is opened or damaged when received, do not use. Visually inspect with particular
attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper
working condition, do not use. Please notify Cook for return authorization.
Store in a dry location, away from temperature extremes.
Use of this device restricted to a trained healthcare professional.
CONTRAINDICATIONS
Those specific to upper GI endoscopy and any procedure to be performed in conjunction
with stent placement.
Additional contraindications include, but are not limited to: total esophageal obstruction,
strictures that cannot be dilated a minimum size as outlined in the precautions section,
placement requiring positioning of stent within 2 cm of the cricopharynx, surgical resection
candidates, hiatal hernia and gastric prolapse in the esophageal area, patients with a
perforated esophagus, placement in actively bleeding tumors, benign diseases.
Relative contraindications include, but are not limited to: uncooperative patient,
coagulopathy, tracheal compression, recent myocardial infarction, cervical arthritis with fixed
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