Cordis S.M.A.R.T.® Transhepatic
Biliary Stent

Essential Prescribing Information

Indications

The Cordis S.M.A.R.T.® Transhepatic Biliary Stent is indicated for palliation of malignant neoplasms in the biliary tree.

Contraindications

  • Stenting of a perforated duct where leakage from the duct could be exacerbated by the prosthesis.
  • Patients with bleeding disorders.
  • Severe ascites.

 

Warnings

  • The safety and effectiveness of this device for use in the vascular system have not been established.
  • Persons with allergic reactions to nickel titanium (nitinol) may suffer an allergic response to this implant.
  • Do not reuse.
  • Do not use with Ethiodol* or Lipiodol* contrast media.
  • Do not expose the delivery system to organic solvents (e.g. alcohol).
  • The stent is not designed for repositioning or recapturing.
  • Stenting across a major bile duct branch could lead to compromised future diagnostic or therapeutic procedures.
  • Any secondary expansion of the biliary stent should be performed with a device indicated for biliary stent placement.

 

Precautions

  • Device intended for use by appropriately trained physicians.
  • The delivery system is not designed for use with power injection systems.
  • Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.

 

Adverse Events

  • Bile duct perforation
  • Liver abscess
  • Pancreatitis
  • Parenchymal hemorrhage
  • Sepsis/infection
  • Sludge occlusion
  • Stent migration
  • Stent misplacement
  • Stent obstruction secondary to tumor in growth through the stent
  • Tumor overgrowth at the stent ends

 

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

 

See package insert for full product information.

*The third-party trademarks used herein are trademarks of their respective owners.