BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1706376 · Received May 28, 2010

    Report

    Report Number
    2024168-2010-01063
    Event Type
    Death
    Date Received
    May 28, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 3, 2010
    Manufacturer
    ABBOTT VASCULAR GERMANY
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE STENT REMAINED IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A F/U WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE PATIENT DEVELOPED PEA (PULSELESS ELECTRICAL ACTIVITY) DURING THE PROCEDURE WITH OCCLUSION OF BOTH THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE CIRCUMFLEX (CX)-BOTH WERE STENTED. THE JOSTENT WAS PLACED IN THE LAD TO TREAT A POSSIBLE PERFORATION. THE PT DIED DURING THE PROCEDURE. NO ADD'L EVENT OR PT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR GERMANY NA 580339

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death