Oct. 30, 2003 -- More than 60 people have died and 290 have developed dangerous blood clots after receiving a device made by the Cordis Corp. called a drug-coated stent, which props open clogged heart arteries, the FDA says.
The blood clots and deaths occurred one to 30 days after a procedure to implant Cordis' Cypher Coronary Stent, the FDA says.
Stents are used along with balloon angioplasty to open up clogged heart arteries and restore blood flow to the heart in people with heart disease. However, blood clots can form on traditional stents. Drug-coated stents are treated with a drug to help reduce the recurrence of these blood clots.
The FDA has also received more than 50 reports of possible allergic reactions to the stents. The symptoms include pain, rash, respiratory alterations, hives, itching, fever, blood pressure changes, and in at least a few instances, death.
According to the FDA, hundreds of thousands of patients with heart disease have been successfully treated with the Cypher stent. At this point, the FDA does not have enough information to determine whether the number of blood clots and allergic reactions with the Cypher stent differs from those experienced with more traditional metal stents.
The Cypher stent was approved in April 2003 for patients undergoing balloon angioplasty to open clogged heart arteries. The stent, a metal mesh cylinder, is designed to keep the arteries from reclogging after the procedure. It is coated with a drug called sirolimus that is slowly released into the artery and is intended to reduce the rate of reblockage that occurs with other stents.
The cause of these side effects has not yet been determined. The FDA and Cordis are working quickly to gather as much information as possible about the circumstances surrounding these events, the FDA says.
The FDA is also working with the regulatory bodies of other countries to get more information about foreign experience with the Cypher stent.
Until FDA gets to the root of the problems, the agency is encouraging doctors to follow the instructions for use of the stent and urging them to be vigilant for any symptoms in their patients that could be attributed to hypersensitivity to the stent.
Patients who have received this stent should continue to follow their regularly scheduled plan for follow-up appointments with their doctor.
As a condition of approval, the FDA is requiring Cordis to continue evaluating patients from ongoing clinical trials to assess the long-term safety and effectiveness of the stent and to look for rare complications that may result from use of the product.
Doctors and patients who have experienced a complication related to the stent are encouraged to report the incident to the FDA online at www.accessdata.fda.gov/scripts/medwatch/; by telephone at (800) FDA-1088; by fax at (800) FDA-0178; or by mail to MedWatch, FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20857.