Evolution® Duodenal Controlled-Release Stent - Uncovered

INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

IMPORTANT INFORMATION
Please review prior to use.

INTENDED USE
This device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.

STENT DESCRIPTION
This flexible, self-expanding stent is constructed of a single, woven, nitinol wire. The stent has a flange at both ends to aid in preventing migration. 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. To aid in visibility under fluoroscopy, there are four tantalum marker bands at either end of the stent. The proximal and distal ends of the stent are designed with numerous rounded “crowns” to potentially reduce tissue trauma.

DELIVERY SYSTEM DESCRIPTION
The stent is mounted on an inner catheter, which accepts a .035-inch wire guide, and is constrained by an outer catheter. An endoscopically and fluoroscopically visible yellow marker defines the proximal end of the stent when constrained in the catheter. A pistol-grip delivery handle allows controlled stent deployment or recapture. The position of the red marker on top of the handle in relation to the point-of-no-return position on the handle label indicates the point after which it is not possible to recapture the deployed stent.

CONTRAINDICATIONS
Those specific to GI endoscopy and any procedure to be performed in conjunction with stent placement. Additional contraindications include, but are not limited to: enteral ischemia • suspected or impending perforation • intra-abdominal abscess/ perforation • inability to pass wire guide or stent through obstructed area • patients for whom endoscopic procedures are contraindicated • coagulopathy/patients with elevated bleeding times • benign disease.

POTENTIAL ADVERSE EVENTS
Potential adverse events associated with GI endoscopy include, but are not limited to: airway obstruction • allergic reaction to contrast or medication • aspiration • biliary obstruction • cardiac arrhythmia or arrest • cholangitis • fever • hemorrhage • hypotension • infection • perforation • reflux • respiratory depression or arrest.

Additional adverse events include, but are not limited to: allergic reaction to nickel • bowel impaction • death (other than due to normal disease progression) • erosion of the luminal mucosa • foreign body sensation • inadequate expansion • intestinal perforation • nausea/vomiting • pain/discomfort • pancreatitis • pressure necrosis • septicemia • stent misplacement and/or migration • stent occlusion • tumor ingrowth or overgrowth • ulcerations.

PRECAUTIONS
Refer to product package label for the minimum channel size required for this device.

A complete diagnostic evaluation must be performed prior to use to determine proper stent size.

If wire guide or stent cannot advance through obstructed area, do not attempt to place stent.

Stent should be placed using fluoroscopic monitoring with endoscopy.

The stent should only be placed with the Cook delivery system, which is provided with each stent.

This device is intended for palliative treatment only. Alternate methods of therapy should be investigated prior to placement.

Long-term patency of this device has not been established. Periodic evaluation is advised.

Stent cannot be retrieved after the deployment threshold has been passed. The position of the red marker on the top of the handle in relation to the point-of-no-return position on the handle label indicates when threshold has been passed.

Do not use this device for any purpose other than stated intended use.

Use of this device is restricted to a trained healthcare professional.

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