Evolution® Esophageal Controlled-Release Stent – Partially Covered Endoscopic Animation

Evolution® Esophageal Controlled-Release Stent – Partially Covered INSTRUCTIONS FOR USE (IFU): https://www.cookmedical.com/data/IFU_PDF/IFU0061-4.PDF MORE INFO: https://www.cookmedical.com/product/-/catalog/evolution--esophageal-partially-covered-controlledrelease-stent?ds=esc_evo_webds 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 ulcerat