WALLSTENT® RX Biliary Endoprosthesis

Prescriptive Information

Indications

The WALLSTENT RX Biliary Endoprosthesis, with or without Permalume™ Covering, is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

Contraindications

Contraindications associated with the use of the WALLSTENT RX Biliary Endoprosthesis, with or without Permalume Covering, include:

• Use of the device in very small intrahepatic ducts
• Stenting of a perforated duct, where leakage from the duct could be exacerbated by the prosthesis and leakage could occur across the uncovered mesh of the stent.
• All of the customary contraindications associated with the endoscopic manipulation of 8 Fr / 2,7 mm caliber catheters within the biliary system.

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.

Stenting across a major bifurcation may prevent or hinder future endoscopic access or other procedures.

A stent cannot be repositioned or removed after the deployment threshold has been exceeded.

Final stent placement resulting in an excessive length of stent protruding into the duodenum or misplacement of the entire stent into the duodenum may damage or obstruct the intestinal tract.

The safety and effectiveness of this device for use in the vascular system have not been established.

Potential Adverse Effects

Potential adverse effects associated with the WALLSTENT RX Biliary Endoprosthesis, with or without Permalume Covering, may include the usual complications reported for conventional biliary stents and endoscopic procedures such as infection or sepsis, stent misplacement, stent migration, and stent obstruction secondary to tumor ingrowth through the stent, tumor overgrowth at the stent ends, sludge occlusion, bile duct perforation or ulceration, bleeding, cholangitis, or pancreatitis.

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.

This device is intended for use by physicians who have received appropriate training on endoscopic placement of the WALLSTENT and the Rapid Exchange (RX) Procedure.

The sterile packaging and device should be inspected prior to use. If sterility or performance of the device is suspect to be compromised, it should not be used.

MR Safe: The WALLSTENT RX Biliary Endoprosthesis will not present an additional hazard or risk to a patient undergoing an MRI procedure using an MR system operating with a static magnetic field of 1.5 Tesla or less.

MR Compatible: Use of the WALLSTENT RX Biliary Endoprosthesis in an MR environment will not adversely impact the image quality.

Trademarks

Permalume and Unistep are trademarks of Boston Scientific Corporation or its affiliates.