Device Description; Intended Use; Contraindications - COOK Medical Evolution Gebrauchsanweisung

ENGLISH
Evolution® Esophageal Stent System – Fully Covered
IMPORTANT INFORMATION: Please review prior to use.
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician
(or a properly licensed practitioner).

DEVICE DESCRIPTION

Stent
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 and distal ends of the stent. There are radiopaque
markers on the proximal and distal ends of the stent.
Delivery System
The 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.

INTENDED USE

This device is used to maintain luminal patency of the esophagus in cases of: obstruction
caused by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal
tracheoesophageal fistulas.
NOTES
• Do not use this device for any purpose other than the stated intended use.
• This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse
may lead to device failure and/or transmission of disease.
• 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 is restricted to a trained healthcare professional.
MALIGNANT AND BENIGN
The above symbol means the following: Malignant and Benign.

CONTRAINDICATIONS

Contraindications include those specific to upper gastrointestinal (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 patients
• hiatal hernia and gastric prolapse in the esophageal area
• patients with a perforated esophagus
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