Potential Complications; Equipment Required; Patient Preparation - COOK Medical Evolution Gebrauchsanweisung

For US Patients Only
Cook recommends that the patient register the MR conditions disclosed in this IFU with
the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following
manners:
Mail:
Phone:
Fax:
Web:

POTENTIAL COMPLICATIONS

Those associated with upper GI endoscopy include, but are not limited to: perforation;
hemorrhage; aspiration; reflux; vomiting; 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 overgrowth; dysphagia, esophageal ulceration and erosion; wire-
entrapment, nausea; pain; foreign body sensation or reaction; esophagitis; edema; food
bolus impaction; gas bloat syndrome; sensitivity to metal components; fistula involving
trachea, bronchi or pleural space; intestinal obstruction secondary to migration; mediastinitis
or peritonitis; airway compression; tracheal obstruction; death (other than due to normal
disease progression).
INSTRUCTIONS FOR USE:

Equipment Required

• Stent and delivery system
• Esophageal Balloon Dilators or Bougie Dilators
• .035 inch wire guide

Patient Preparation

1. Intubate the patient using an endoscope per standard procedure. Assess the stricture
location and dimensions upon direct visualization.
2. If required, dilate stricture to a minimum size as outlined in the Precautions section
using Balloon Dilators or Bougie Dilators.
3. Endoscopically locate and mark upper and lower margins of lesion with radiopaque
marker, internal or external, or use an injectable radiopaque substance. CAUTION:
Accurate marking of lesion borders is essential for proper stent selection and
placement.
4. The esophageal stent should be at least 4 cm longer than the stricture, allowing for
approximately 2 cm longer at either end of the stricture.
5. Place a .035 inch wire guide, floppy tip first, through accessory channel, through
stricture, until it is fluoroscopically visualized in stomach. Leave wire guide in place
and remove endoscope.
MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
888-633-4298 (toll free)
209-668-3333 from outside the US
209-669-2450
www.medicalert.org
9