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Cypher Stent and Thrombosis
The FDA has received more than 290 reports of thrombosis (clotting) in patients who received Cypher stent implants to open clogged arteries. In more than 60 of these cases, the patients died.
Cypher Stent: FDA Informs Doctors About Problems
Based on these reports, in October 2003, the Food and Drug Administration announced to physicians that the Cypher stent has been associated with adverse events in patients who received the device. Physicians were informed that the patients suffered blood clots after surgery. These clots were serious enough to require additional medical or surgical intervention and resulted in 60 patient deaths.
The FDA also reported 50 cases, including some deaths, that are believed to be possible hypersensitivity reactions. Symptoms in these cases include pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes.
Cypher Stent Background Information
The FDA approved the Cypher stent in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. The stent, a cylindrical metal mesh, is designed to keep the arteries from reclogging after the procedure. The stent is manufactured by Cordis Corporation, a subsidiary of Johnson & Johnson. Since its approval, hundreds of thousands of patients have been treated with the Cypher stent.