Evolution® Esophageal Controlled-Release Stent – Partially Covered / Fully Covered
INSTRUCTIONS FOR USE (IFU):
INTENDED USE: This device is used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistulas.
STENT DESCRIPTION: This flexible, self-expanding stent is constructed of a single, woven, nitinol wire. The stent foreshortens due to its design. The total length of the stent is indicated by radiopaque markers on the inner catheter, indicating the actual length of the stent at nominal stent diameter. There is a lasso at the proximal end of the stent (partially covered) or the proximal and distal ends of the stent (fully covered), purpose is to reposition the stent in the event of incorrect placement.
DELIVERY SYSTEM DESCRIPTION: Stent is mounted on an inner catheter, which accepts a .035 inch wire guide, and is constrained by an outer catheter. A pistol-grip delivery handle allows stent deployment or recapture.
NOTES: Do not use this device for any purpose other than stated intended use.
Part numbers with the prefix EVO-FC are Fully Covered.
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.
Store in a dry location, away from temperature extremes.
Use of this device restricted to a trained healthcare professional.
CONTRAINDICATIONS: Those specific to upper GI endoscopy and any procedure to be performed in conjunction with stent placement.
Additional contraindications include, but are not limited to: total esophageal obstruction, strictures that cannot be dilated a minimum size as outlined in the precautions section, placement requiring positioning of stent within 2 cm of the cricopharynx, surgical resection candidates, hiatal hernia and gastric prolapse in the esophageal area, patients with a perforated esophagus, placement in actively bleeding tumors, benign diseases.
Relative contraindications include, but are not limited to: uncooperative patient, coagulopathy, tracheal compression, recent myocardial infarction, cervical arthritis with fixed 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.