Evolution® Esophageal Controlled-Release Stent System – Partially Covered / Fully Covered

INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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INTENDED USE
This device is used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistulas.

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 to 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 ADVERSE EVENTS
Those associated with upper GI endoscopy include, but are not limited to: allergic reaction to contrast or medication • aspiration • cardiac arrhythmia or arrest • fever • hemorrhage • hypotension • infection • perforation • reflux • respiratory depression or arrest • vomiting.

Additional adverse events include, but are not limited to: airway compression • allergic reaction to nickel • aortoesophageal fistula and arterioesophageal fistula • chest or retrosternal pain • death (other than due to normal disease progression) • dysphagia • edema • erosion or perforation of stent into adjacent vascular structures • esophageal ulceration and erosion • esophagitis • fistula involving trachea, bronchi or pleural space • food bolus impaction • foreign body sensation or reaction • gas bloat • inadequate stent expansion • intestinal obstruction secondary to migration • mediastinitis or peritonitis • nausea • pain/discomfort • reocclusion • sensitivity to metal components • sepsis • stent misplacement and/or migration • tracheal obstruction • tumor ingrowth or overgrowth • wire entrapment.

PRECAUTIONS
A complete diagnostic evaluation must be performed prior to use to determine proper stent size.

Part numbers with the prefix EVO-FC are Fully Covered.

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 of 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.

Long-term patency of this device has not been established. Periodic evaluation is advised.

This device shortens upon deployment. With proximal strictures near the upper esophageal sphincter, deployment should be performed under fluoroscopic visualization as this may enhance placement accuracy.

Do not use this device for any purpose other than stated intended use.

Stent cannot be retrieved after the deployment threshold has been passed. The position of the red marker on top of the handle in relation to the point-of-no-return position on the handle label indicates when the threshold has been passed.

Use of this device is restricted to a trained healthcare professional.

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