BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER STENT

    MDR report key: 487036 · Received September 9, 2003

    Report

    Report Number
    MW1029551
    Event Type
    Injury
    Date Received
    September 9, 2003
    Date of Event
    September 8, 2003
    Report Date
    September 9, 2003
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACUTE THROMBOSIS OF CYPHER STENTS IN PROXIAL LAD AND RCA RESULTING IN ACUTE MI AND CARDIOGENIC SHOCK. STENTS IMPLANTED IN 2003, PT TREATED WITH ASA 81 MG AND CLOPIDOGREL 75 MG Q D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER STENT INTRACORONARY STENT NIQ CORDIS CORPORATION CWS18300 40603146

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening