Potential Complications - COOK Medical Evolution Instrucciones De Uso

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 COMPLICATIONS

Those associated with GI endoscopy include, but are not limited to:
perforation, hemorrhage, aspiration, reflux, fever, infection, allergic
reaction to medication, hypotension, respiratory depression or arrest,
cardiac arrhythmia or arrest.
Additional complications include, but are not limited to: pancreatitis,
intestinal perforation, pain, inadequate expansion, stent misplacement
and/or migration, tumor ingrowth or overgrowth, stent occlusion,
ulcerations, pressure necrosis, erosion of the luminal mucosa, septicemia,
foreign body sensation, bowel impaction, death (other than due to
normal disease progression).
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.
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.
Long-term patency of this device has not been established. Periodic
evaluation is advised.
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