November 25, 2003—The Federal Food and Drug Administration (FDA) has linked
more than seventy deaths to the Cypher coronary stent, manfactured by Cordis Corporation, a subsidiary
of Johnson & Johnson. The FDA has warned physicians about the risk of blood clots and other serious
side effects associated with the Cordis Cypher stent.
In its letter to doctors, the FDA noted that more than 360 instances of blood clots (thrombosis)
occurred within 30 days following surgery. The stent is a small wire mesh device used to keep coronary
arteries open after angioplasty surgery.
The stent was also associated with other serious problems, including hypersensitivity to the stents.
Symptoms of this reaction include:
- respiratory problems
- blood pressure fluctuations
In July 2003, Cordis acknowledged there were potential risks of blood clots associated with the
Cypher stent. This warning came in a letter to health care professionals. Cordis did not provide
an explanation of what they believed was causing the problems experienced by some of the Cypher stent