Evolution® Colonic Controlled-Release Stent Quick Reference Video

Evolution® Colonic Controlled-Release Stent - Uncovered
INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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INTENDED USE
This device is used for palliative treatment of colonic obstruction or colonic strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
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 • significant coagulopathy • benign disease.
POTENTIAL ADVERSE EVENTS
Potential adverse events associated with GI endoscopy include, but are not limited to: allergic reaction to contrast or medication • aspiration • cardiac arrhythmia or arrest • fever • hemorrhage • hypotension • infection • perforation • respiratory depression or arrest.
Additional adverse events include, but are not limited to: allergic reaction to nickel • bowel impaction • constipation • death (other than due to normal disease progression) • diarrhea • erosion of the luminal mucosa • foreign body sensation • inadequate stent expansion • intestinal perforation • nausea/vomiting • pain/discomfort • peritonitis • pressure necrosis • septicemia • stent misplacement and/or migration • stent occlusion • symptoms of tenesmus or urgency/incontinence • 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 endoscopically with fluoroscopic monitoring.
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.
Use of this device is restricted to a trained healthcare professional.
Do not use this device for any purpose other than stated intended use.
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.
WARNINGS
The stent is not intended to be removed or repositioned after stent placement and is intended to remain in the body permanently. Attempts to remove or reposition stent after placement may cause damage to surrounding tissue or mucosa.
This stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity.
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.
To minimize pain and tenesmus, the stent end nearest to the anal canal/ anus should be placed 2 cm above the anal canal or 6 cm from the anus.
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.
After stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumor shrinkage, stent erosion, and/or mucosal bleeding.
The device should be used with caution and only after careful consideration in patients with:
• Patients with radiation colitis or proctitis.
• Patients with elevated bleeding times, coagulopathies.