Biliary stents are permanently implanted flexible tubular devices intended for use to treat bile duct obstruction due to malignancies. They function to drain the biliary tract and to keep the bile duct open. Uses outside of the biliary tract, i.e., in the cardiovascular or other systems, have not been cleared by the FDA.
In May 2004, the U.S. Food and Drug Administration issued a Class I recall of the PRECISE Stent's instructions for use. Some physicians use this device, made by Cordis Corporation, for vascular use. This use has not been cleared by the FDA. When used this way, air may be introduced into the patient via the stent system causing serious problems including
coma,
seizure and
stroke. There have been nine patient injuries due to air embolism and seven incidents of malfunction in connection with the use of this system outside of its approved indications. Cordis strongly recommends that physicians limit the use of the PRECISE RX Stent to FDA-approved uses only.
If you have suffered injuries due to the PRECISE Stent, it may be important to
contact an attorney who can help you protect your legal rights. Please keep in mind that there may be
time limits within which you must commence suit.
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See Also
- Medical Devices & Implants
- Coma: Overview
- Seizures: Overview
- Stroke