BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1686038 · Received May 11, 2010

    Report

    Report Number
    2024168-2010-00956
    Event Type
    Death
    Date Received
    May 11, 2010
    Date of Event
    April 13, 2010
    Report Date
    April 16, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    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 CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE ISSUE: FAILURE TO CROSS TO TREAT PERFORATION. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: REQUIRED INTERVENTION SUBSEQUENT DEATH. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING DILATATION OF THE CIRCUMFLEX VESSEL WITH A VOYAGER NC WHICH WAS PRESSURIZED TO 12 ATM, A PERFORATION OCCURRED. THE GRAFTMASTER STENT WAS BEING USED TO TREAT THE PERFORATION; HOWEVER, IT WAS UNABLE TO CROSS. THEREFORE, COILING OF THE CORONARY ARTERY WAS PERFORMED AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT DIED SIX DAYS LATER. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 525072

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| R