WallFlex® Biliary RX Uncovered Stent System

Prescriptive Information

Refer to the operator's manual for complete instructions for use.

Intended Use/Indications for Use

The WallFlex Biliary RX Uncovered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

Contraindications

Contraindications may be found in the product labeling supplied with each device.

The WallFlex Biliary RX Uncovered Stent System is contraindicated for:

• Placement in biliary strictures caused by benign tumors, as the longterm effects of the stent in the bile duct is unknown.
• Placement in strictures that cannot be dilated enough to pass the delivery system.
• Placement in a perforated duct.
• Placement in very small intrahepatic ducts.
• Those patients for whom endoscopic techniques are contraindicated.
• Any use other than those specifically outlined under indications for use.

Warning

Warnings may be found in the product labeling supplied with each device.

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

No warranty is made with regard to removability of this device by endoscopic means or otherwise.

Potential Complications

Potential complications may be found in the product labeling supplied with each device.

The following complications have been reported in the literature for biliary prostheses.

These include, but are not limited to:

• Pain
• Bleeding
• Fever
• Nausea
• Vomiting
• Infection
• Inflammation
• Recurrent obstructive jaundice
• Stent occlusion
• Tumor ingrowth through the stent
• Tumor overgrowth around ends of stent
• Mucosal hyperplasia
• Cholangitis
• Cholecystitis
• Pancreatitis
• Bile duct ulceration
• Perforation of duodenum or bile duct
• Stent migration
• Death (other than that due to normal disease progression)
• Stent misplacement

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.

Magnetic Resonance (MR) Safe: The WallFlex Biliary RX Uncovered Stent will not present an additional hazard or risk to a patient in a 3 Tesla MRI environment or less with regard to translational attraction, torque and heating.

Magnetic Resonance (MR) Compatibility: Artifacts created by the presence of the WallFlex Biliary RX Uncovered Stent were shown as localized signal voices (i.e., signal loss) that were minimal in size relative to the size and shape of these implants. MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of a WallFlex Biliary RX Uncovered Stent. Therefore, it may be necessary to optimize MR imaging parameters for the presence of these metallic implants.

Excessive force should not be used to position or deploy the stent. This may cause inadvertent damage to the device and/or endoscope.

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