Potential Complications - COOK Medical Evolution Instructions For Use Manual

cervical spine, large tumor mass occupying the mediastinum, nonobstructive tumor, gastric
outlet obstruction, necrotic esophageal mucosa, acutely angled stenosis.

POTENTIAL COMPLICATIONS

Those associated with upper 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: stent misplacement and/or
migration; tumor ingrowth or overgrowth; esophageal ulceration and erosion; nausea; chest
or retrosternal pain; foreign body sensation; food bolus impaction; gasbloat; sensitivity to
metal components; fistula involving trachea, bronchi or pleural space; intestinal obstruction
secondary to migration; mediastinitis or peritonitis; airway compression; tracheal obstruction.
PRECAUTIONS
A complete diagnostic evaluation must be performed prior to use to determine proper stent
size.
Stent should be placed using fluoroscopic monitoring.
Stent should only be placed with the Cook delivery system, which is provided with each
stent.
Note: Prior to advancing system, area to be stented should be dilated to:
For (18mm x 23mm) stent – a minimum 9 mm and a maximum of 11 mm. If area is dilated
greater than 11 mm, stent may migrate.
For (20mm x 25mm) stent – a minimum of 10 mm and a maximum of
14 mm. If area is dilated greater than 14 mm, stent may migrate.
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.
After stent placement, patients should be instructed to chew food well or eat soft or pureed
food.
This device shortens upon deployment. With proximal strictures near the upper esophageal
sphincter, deployment should be preformed under fluoroscopic visualization as this may
enhance placement accuracy.
WARNINGS
MR CONDITIONAL: Non-clinical testing has demonstrated that this stent is MR Conditional. It
can be scanned safely under the following conditions:
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