Instructions for Use - Xceed Biliary Self-Expanding Stent System (U.S.)

Rx ONLY

Indications for Use

The Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Contraindications
Contraindications associated with the use of transhepatic biliary endoprosthesis include:

• Stenting of a perforated duct where leakage from the duct could be enhanced by the prosthesis
• Bleeding disorders
• Severe ascites
• Active infections

Warnings

• The safety and effectiveness of this device for use in the vascular system have not been established.
• The device is provided STERILE for single use only and must be used by the "use before date" printed on the package. Do not resterilize and/or reuse this device.
• Carefully inspect the sterile package and device prior to use. DO NOT use if either has been damaged or compromised.
• The stent is not designed for capture or repositioning after deployment.
• DO NOT attempt to reconstrain the stent at any time during deployment.
• Persons allergic to nickel titanium may suffer an allergic reaction to this implant.
• Do not use with Ethiodol® or Lipiodol™ contrast media.
• Stenting across a major bile duct may compromise future procedures.
• Do not expose the delivery system to organic solvents (e.g., alcohol).

Precautions

• Store in a cool, dry place.
• Should unusual resistance be felt at any time during the procedure, the introducer sheath/guiding catheter and stent system should be carefully withdrawn as a single unit (applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components).
• If unusual resistance is encountered when attempting to deploy the stent, rotate the thumb knob counterclockwise back to its original position, and relock. Carefully withdraw the stent system as a single unit and discard.
• Special care must be taken not to handle or in any way disrupt the stent on the delivery system. This is most important during delivery system removal from packaging, placement over the guide wire, and advancement through the introducer.
• This device is intended for use by physicians familiar with the complications, side effects, and hazards associated with biliary stent placement.
• The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is intended to perform as a system. Individual system parts should not be removed for use in conjunction with other devices (e.g. dilatation catheters stents, etc.).
• The usage of other stents in conjunction with the Xceed Biliary Stent System is not recommended. When multiple stents are required, and the user elects to use an alternative stent, stent materials should be of similar composition. Refer to the instructions for use supplied with any interventional devices to be used in conjunction with the Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, for their intended uses, contraindications, and potential complications.
• The delivery system is not designed for use with powered injection systems.

Potential Complications
Potential complications associated with the use of a biliary endoprosthesis may include, but are not limited to:

• Sepsis/infection
• Bile duct occlusion/obstruction
• Tumor overgrowth
• Bile duct perforation
• Hemobilia
• Abscess
• Cholangitis
• Peritonitis
• Pancreatitis
• Parenchymal hemorrhage
• Stent migration

100-0969-B(7/08)

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