Cypher Coronary Stent

The U.S. Food and Drug Administration (FDA) has announced that the agency is warning physicians about blood clots and other side effects associated with the Cypher stent, manufacured by Cordis Corporation, a subsidiary of Johnson & Johnson. The device has been linked to more than 60 deaths.

FDA Reports Cypher Stent Patients Have Suffered Serious Injuries
In a letter to physicians, the FDA said that the company's drug-coated stent, a tiny wire mesh device used to keep the coronary arteries open after angioplasty procedures, has resulted in more than 290 cases of thrombosis (blood clots) within 30 days after patients received the device. In more than 60 of those cases, the patients died. In other cases, the stent caused serious injuries requiring surgical or medical intervention.

The FDA has also received more than 50 reports of possible hypersensitivity reactions to these stents. Symptoms included pain, rash, respiratory problems, hives, itching, fever and changes in blood pressure.

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