COOK Medical Evolution EVO-20-25-8-E, Instructions For Use Manual

Page: 6 / 136

6
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 COMPLICATIONS
Those associated with GI endoscopy include, but are not limited to:
perforation, hemorrhage, fever, infection, allergic reaction to medication,
hypotension, respiratory depression or arrest, cardiac arrhythmia or
arrest.
Additional complications include, but are not limited to: intestinal
perforation, pain, inadequate Stent 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, diarrhea, constipation, peritonitis,
symptoms of tenesmus or urgency/incontinence, 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 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.
After stent placement, alternative methods of treatment such as
chemotherapy and radiation should not be administered as this may