BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 1286223 · Received January 9, 2009

    Report

    Report Number
    9616099-2009-00033
    Event Type
    Death
    Date Received
    January 9, 2009
    Date of Event
    December 31, 2008
    Report Date
    January 2, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K021898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THESE DEVICES ARE NOT AVAILABLE FOR EVALUATION AND TESTING, AS THE REMAIN IMPLANTED. HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. NOTE: TWO DEVICES WITH THE SAME CATALOG AND UNKNOWN LOT NUMBERS ARE REPRESENTED BY THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED FOR A LESION IN THE EXTERNAL ILIAC ARTERY, AS WELL AS A LESION IN THE PROXIMAL-LEFT ANTERIOR DESCENDING ARTERY (PLAD). BOTH LESIONS WERE STENTED SUCCESSFULLY AND WITHOUT INCIDENT. TWO OVERLAPPING SMART CONTROL STENTS WERE IMPLANTED IN THE EXTERNAL ILIAC, AND A CYPHER STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). HOWEVER, THE FOLLOWING DAY, THE PATIENT COLLAPSED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death