Gastroenterology

Prescriptive Information

Refer to the Directions for Use for complete instructions for use.

Indications
The WallFlex Esophageal Partially Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

Contraindications
The WallFlex Esophageal Partially Covered Stent System is contraindicated for:

• Placement in esophageal strictures caused by benign tumors, as the long-term effects of the stent in the esophagus are unknown.
• Placement in strictures that cannot be dilated enough to pass the endoscope or the delivery system.
• Placement of the proximal end of stent within 2 cm of the cricopharyngeal muscle.
• Placement in an esophago-jejunostomy (following gastrectomy), as peristalsis and altered anatomy may displace stent.
• Placement in necrotic chronically bleeding tumors, if bleeding is active at the time of placement.
• Placement in polypoid lesions.
• Those patients for whom endoscopic techniques are contraindicated.
• Any use other than those specifically outlined under indications for use.
• Placement in patients who have an underlying bleeding diathesis.

Warnings
The WallFlex Esophageal Stent System should be used with caution and only after careful consideration in patients with:

• Strictures exceeding 12 cm in length
• Significant preexisting pulmonary or cardiac disease

Potential Adverse Effects
The potential adverse effects associated with esophageal stent placement may include:

• Bleeding
• Perforation
• Pain
• Aspiration
• Stent migration
• Tumor ingrowth through uncovered portion of stent
• Tumor overgrowth around stent ends
• Foreign body sensation
• Food bolus impaction
• Reflux
• Esophagitis
• Edema
• Ulceration
• Fever
• Infection
• Sepsis
• Septicemia
• Recurrent dysphagia
• Fistula formation
• Tracheal compression/obstruction (or acute airway compression)
• Hematemesis
• Death (other than that due to normal disease progression)

Possible Post Stent Complications

• Sensitivity to the metal component of the stent
• Mediastinitis
• Aspiration
• Intestinal obstruction (secondary to stent migration)

Instructions in the Event of Damage
Warning: Visually inspect the system for any signs of damage. Do not use if the system has any visible signs of damage. Failure to observe this warning may result in patient injury.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.