WALLSTENT® Colonic & Duodenal Endoprosthesis

Prescriptive Information

Indications

Indicated for the palliative treatment of colonic, duodenal or gastric outlet obstruction or strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

Contraindications

Contraindications include:

• Enteral ischemia
• Suspected or impending perforation
• Intra-abdominal abscess/perforation

Warnings

Our devices are designed, manufactured, tested, validated and labeled for single use only. These devices should not be reused, reprocessed or resterilized. 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.

Stents cannot be repositioned after the deployment threshold has been exceeded.

Potential Adverse Effects

Potential adverse effects may include the usual complications reported for conventional stents and endoscopic procedures such as infection, stent misplacement, stent migration, intestinal perforation and stent obstruction secondary to tumor ingrowth through the stent, tumor overgrowth at the stent ends, or occlusion.

Post stent placement complications may include: bleeding, perforation, pain, stent migration, tumor ingrowth through stent, tumor overgrowth around ends of stent, foreign body sensation, bowel impaction, reflux, ulceration, fever, septicemia, and death (other than that due to normal disease progression).