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

Rx ONLY

INDICATIONS
The Xpert(tm) Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant strictures in the biliary tree.

CONTRAINDICATIONS
All of the customary contraindications to percutaneous transhepatic manipulation of catheters of the same caliber as the pert(tm) Self-Expanding Transhepatic Biliary Stent System apply, including but not limited to:

• Ascites
• Extensive metastatic disease or tumour spread through the liver
• Intra-arterial chemotherapy

Also including

• Stenting a perforated duct, whereby leakage from the duct could be exacerbated by the self-expandable endoprosthesis and leakage could occur across the mesh of the stent
• Failure to pass the stricture with a guidewire

WARNINGS

• The safety and effectiveness of this device for use in the vascular system have not been established.
• Single use only - do not resterilize. Do not use if inner package is damaged or opened.
• Use prior to the "use by" date. Store in a cool, dry place.
• Once the expansion of the stent has begun, the stent cannot be retracted into the delivery system or repositioned.
• The system must always be introduced, moved or withdrawn over a guidewire (0.018").

PRECAUTIONS

• This device should only be used by physicians who have a thorough understanding and experience in the clinical and technical aspects of biliary stenting.
• When the system is introduced into the bile duct, it should only be manipulated under high quality fluoroscopy.
• The delivery system is not designed for the use of power injection.
• Do not use with Lipiodol(tm) or Ethiodol(tm) contrast media.
• Do not advance the Xpert(tm) Self-Expanding Transhepatic Biliary Stent System against significant resistance. The cause of resistance should be determined via fluoroscopy and remedial action taken.
• The stent should deploy easily. Do not deploy it if unusual force is required, since this indicates a failed system. Use a new system instead.

POTENTIAL COMPLICATIONS
Complications Relevant to Transhepatic Stent Implantations, e.g.

• Bleeding
• Parenchymal or intraperitoneal hemorrhage
• External biliary fistula
• Perforation, or duodenal perforation
• Cholangitis, possibly leading to sepsis
• Cholecystitis
• Liver abscess
• Biliary peritonitis
• Pleural effusion
• Dislocation
• Death

Complications Related to Concomitant Medication, e.g.

• Drug reactions
• Bleeding from anticoagulation/antiplatelet medication
• Allergic reactions to contrast medium

Complications Related to the Use of the Stent Delivery System, e.g.

• Noncompliance with sterility precautions may lead to infection complications.
• Faulty placement technique may lead to failure in deploying the stent, incorrect implantation of the stent
• Inadequate anchoring due to selection of a too small stent, or intimal trauma if the stent is too large
• Stent migration

IU-008215-001/001

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