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In July 2003, Cordis Corp. issued a letter to health care professionals warning of the rare but potential risk of thrombosis associated with the use of its product the CYPHER Sirolimus-Eluting Coronary Stent (CYPHER stent). The CYPHER stent was approved by the U.S. Food & Drug Administration (FDA) in April 2003 for patients undergoing angioplasty to open clogged arteries.
Cordis reports that more than 450,000 units have been distributed worldwide. As of October 2003, the FDA
more than 290 reports involving sub-acute thrombosis (SAT) associated with the CYPHER stent. More than 60 reports of SATs were associated with patient death and the remaining reports were associated with patient injury requiring medical or surgical intervention. Also, The FDA has received more than 50 reports, including some deaths, that Cordis considers possible hypersensitivity reactions. The symptoms reported include: pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes.
Cordis and the FDA has made the following recommendations to health care professionals to reduce the chance of adverse events. The diameter of the stent should match the diameter of the vessel as closely as possible. The stent is indicated for improving coronary luminal diameter in previously untreated vessels and is not indicated for the treatment of restenosis (reclogging of a previously stented vessel). The stent should be fully deployed and in contact with the vessel wall, as poor stent deployment is a factor that can increase the thrombosis risk. |
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