MHRA DES warning issued
This article was originally published in The Gray Sheet
Executive Summary
J&J/Cordis' Cypher drug-eluting stent "must be fully deployed and in contact with the target vessel wall," according to a Sept. 1 1Medical Device Alert issued by the UK's Medicines & Healthcare products Regulatory Agency. Three thrombotic events in the UK have been reported to Cordis out of about 9,000 stents implanted since the device became available in Europe in April 2002, the alert notes. Worldwide, 142 instances of thrombosis have been reported from approximately 226,000 Cypher implants, including 117 incidents in the U.S. In July, Cordis sent a "Dear Colleague" letter to physicians warning against over-expansion of the Cypher after 47 instances of sub-acute thrombosis were reported (2"The Gray Sheet" July 14, 2003, p. 9)...