Cordis Cypher Stent
Fatal Blood Clots Linked to Cordis Cypher Stent
The Cypher Stent, manufactured by Johnson & Johnson’s Cordis unit, is a cylindrical-shaped device made of metal mesh. It works by propping open clogged or blocked arteries during angioplasty procedures and slowly releasing a drug (sirolimus) that helps to reduce the rate of artery re-blockage. Since its approval in 2003, several warnings have been issued concerning the device, calling attention to the serious risk of fatal blood clots and hypersensitivity reactions in patients fitted with the stent.
FDA CORDIS CYPHER STENT WARNINGS
2003— The FDA issued a Public Health Notification after receiving 290 reports of thrombosis (blood clots) leading to at least 60 deaths in patients who received the Cordis Cypher stent. The FDA also received more than 50 reports (including some deaths) of hypersensitivity reactions including: pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes.
2006—An FDA Panel urged the agency to change the labels of the two approved coronary stents (including the Cordis Cypher stent) to warn that off-label use may increase the risk of thrombosis, myocardial infarction, and death.
2011—The FDA issued a Warning Letter to Cordis over violations found during an inspection of their Puerto Rico plant in 2010. Inspectors found that stents produced at the plant failed to meet certain required quality specifications. Cordis plans to stop manufacturing the Cypher stent later this year.