Ultraflex™ Precision Colonic Stent System

Prescriptive Information

Indications

The Ultraflex Precision Colonic Stent System is indicated for palliative treatment of colonic strictures in the descending colon, sigmoid colon and rectum caused 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 Ultraflex Precision Colonic Stent System include: enteral ischemia; complete colonic obstruction preventing passage of a guidewire; suspected, impeding or concurrent perforated colon or rectum; intra-abdominal abscess/perforation; patients for whom colonoscopic procedures are medically contraindicated; and any use other than those specifcally outlined under the Indications for Use.

Warnings

For single 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.

The Ultraflex Precision Colonic Stent System should be used with caution and only after careful consideration in patients with elevated bleeding times or coagulopathies, or in patients with radiation colitis or proctitis.

Stent cannot be repositioned after complete deployment.

The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity.

The safety and effectiveness of this device for use in benign colonic strictures have not been established.

Chemoradiation therapy or radiotherapy alone may lead to tumor shrinkage and subsequent stent migration.

To minimize pain and tenesmus, the proximal stent end should be placed 2cm above the anal canal or 6cm from the anus.

Potential Adverse Effects

Potential Adverse Effects that may occur include but are not limited to:

Procedural Complications: bleeding; perforation of the colon or rectum with potential for peritonitis; pain; or stent misplacement or inadequate expansion.

Post-Stent Placement Complications: stent migration; stent obstruction due to colon entrapment; stent occlusion due to tumor/hyperplastic tissue ingrowth; stent occlusion due to tumor overgrowth of stent ends; symptoms of tenesmus or urgency/incontinence; bleeding as melena or hematochezia; colon or rectum ulceration and/or perforation; peritonitis; septicemia; local infection; foreign body sensation; bowel obstruction/fecal impaction; fever; death (other than that related to normal disease progression); abdominal/perianal pain; rectal bleeding; diarrhea; or constipation.

Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Cautions

Cautions can be found in the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.