Article: FDA: reports of adverse events, deaths related to Cypher stent.

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) ...

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