BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1994128 · Received February 16, 2011

    Report

    Report Number
    2024168-2011-00935
    Event Type
    Death
    Date Received
    February 16, 2011
    Date of Event
    February 6, 2009
    Report Date
    February 12, 2009
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. MYOCARDIAL INFARCTION (MI), THROMBOSIS, AND DEATH ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY 2 MONTHS POST IMPLANTATION OF A XIENCE V STENT IN THE 1ST OBTUSE MARGINAL (1ST OM) ARTERY, A LATE STENT THROMBOSIS OCCURRED, RESULTING IN A MYOCARDIAL INFARCTION. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED AND ON (B)(6) 2009, THE EVENT RESOLVED. ON (B)(6) 2009, THE PATIENT DIED FROM BIVENTRIULAR FAILURE. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8082061

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death CLOPIDOGREL, ASPIRIN