BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS CORPORATION

    MDR report key: 499916 · Received December 5, 2003

    Report

    Report Number
    499916
    Event Type
    Injury
    Date Received
    December 5, 2003
    Date of Event
    November 1, 2003
    Report Date
    November 10, 2003
    Manufacturer
    CORDIS CORP
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRUG-COATED CYPHER STENT (SIROLIMUS-ELUTING CORONARY STENT) PLACED IN PT'S CIRCUMFLEX ARTERY IN 2003 IN CATH LAB. TWO WEEKS LATER, PT PRESENTED TO EMERGENCY ROOM WITH ACUTE MI. PT CATHETERIZED IN CATH LAB; STENT FOUND TO HAVE THROMBOSED. EMERGENCY CORONARY ARTERY BYPASS SURGERY PERFORMED ON PT IN THE OPERATING ROOM. PT RECOVERED FROM SURGERY. PER CATH LAB SURGEON, THERE WAS NO PHYSICAL DEFECT IN THE STENT AND THERE IS A DISTINCT POSSIBILITY THAT THE PT WAS NOT FOLLOWING ANTI-COAGULANT THERAPY AS PRESCRIBED FOLLOWING THE STENT IMPLANTATION. A REVIEW OF THE FDA PRODUCT RECALL DATABASE INDICATES THAT THE FDA IS MONITORING THIS PARTICULAR DRUG-ELUTING STENT AND HAS REQUESTED REPORTING ANY ADVERSE INCIDENTS UNDER MEDWATCH SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS CORPORATION CYPHER (SIROLIMUS-ELUTING STENT) NIQ CORDIS CORP CXS23250 Y0703397

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R OPEN HEART SURGERY, BALLOON PUMP, 2003.