CONTRAINDICATIONS
Contraindications for the BARD ® ELUMINEXX ® Biliary Stent include, but may not be limited to:
• Stenting of a perforated duct where leakage from the duct could be exacerbated by the endoprosthesis.
• Severe ascites precluding a percutaneous transhepatic approach.
• Extensive hepatic metastases precluding a percutaneous transhepatic approach.
• Impossibility of intraductal sounding.
• Uncorrected bleeding disorders.
WARNINGS:
• Should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit.
• Patients with known hypersensitivity to nickel-titanium may suffer an allergic reaction to this implant.
• Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures.
• 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 distal end of the stent should protrude no more than 5 mm beyond the ampulla into the duodenum.
• The safety and effectiveness of this device for use in the vascular system have not been established.
PRECAUTIONS
This device is intended for use only by physicians who are familiar with the principles, clinical applications, complications, side effects, and risks commonly associated with biliary stenting. It is strongly recommended that physician operators adhere to all applicable institutional, local, state, and federal guidelines and protocols regarding adequate procedural training.
