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Article: FDA: reports of adverse events, deaths related to Cypher stent.
- Article from:
- Medical Device Daily
- Article date:
- October 30, 2003
CopyrightCOPYRIGHT 2003 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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FDA: reports of adverse events, deaths related to Cypher stent
By DON LONG
Medical Device Daily Managing Editor
The FDA on Wednesday issued a public health notification reporting on a variety of adverse events associated with use of the very first drug-eluting stent commercialized in the U.S., the Cypher, made and distributed by the Cordis (Miami Lakes, Florida) subsidiary of Johnson and Johnson (New Brunswick, New Jersey).
These adverse events include more than 60 deaths associated with thrombosis following stent placement, the agency said.
The FDA said the reports were first received by its Medical Device Reporting (MDR) ...