WallFlex® Colonic Stent

Prescriptive Information

Indications

The device is indicated for the palliative treatment of Colonic strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

Contraindications

Contraindications associated with the use of the WallFlex Enteral Colonic Stent include:

• Enteral ischemia
• Suspected or impending perforation
• Intra-abdominal abcess/perforation
• Strictures that do not allow passage of a guidewire
• Patients for whom endoscopic technique are contraindicated
• Any use other than those specifically outlines under indications for use

Warnings

• The device should be used with caution and only after careful consideration in patients with elevated bleeding times, coagulopathies, or in patients with radiation colitis or proctitis.
• Stents cannot be repositioned after complete deployment.
• The safety and effectiveness of this device for use in benign strictures have not been established.
• Chemoradiation therapy or radiotherapy alone may lead to tumor shrinkage and subsequent stent migration.
• The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity.
• To minimize pain and tenesmus, the proximal stent end should be placed 2cm above the anal canal or 6cm from the anus.

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative.

For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Potential Adverse Effects

Complications associated with the use of the WallFlex Enteral Colonic Stent may include:

Procedural Complications

• Bleeding
• Pain
• Stent misplacement or inadequate expansion
• Intestinal perforation
• Death