Stents Linked to Deaths, Clots, FDA Says
More Than 60 Deaths Attributed to Device That Props Open Arteries in Heart
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
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
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
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
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.