WallFlex® Biliary RX Stents

Prescriptive Information

Refer to the device directions for use for complete instructions on device use.

Intended Use/Indications for Use

The WallFlex Biliary RX Stents are 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 Stents are 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

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 Complications

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

For the WallFlex Biliary RX Uncovered Stent, the following complications have been reported in the literature for biliary prostheses. For the WallFlex Biliary RX Partially Covered and Fully Covered Stents, the following complications have been reported in the literature for biliary prostheses or have been observed in the Boston Scientific clinical trial of this device.

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
• Perforation of the gall bladder due to the stent covering the cystic duct

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.

*In a small clinical trial of this device, two out of four (50%) of subjects who had a stent placed across the cystic duct developed Cholecystitis. One of these subjects suffered a perforated gall bladder due to the stent covering the cystic duct, requiring a drain to be placed.

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.

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.

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

MR Conditional

Non-clinical testing has demonstrated that the Partially Covered, Fully Covered, and Uncovered WallFlex Biliary RX Stent System is MR Conditional. A patient with this device may undergo MRI immediately under the following conditions:

• static magnetic field of 3 Tesla or less
• maximum spatial magnetic gradient field of 720 Gauss/cm or less
• maximum whole body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning