BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1002974 · Received February 25, 2008

    Report

    Report Number
    2024168-2008-00142
    Event Type
    Death
    Date Received
    February 25, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 29, 2008
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: ENGINEERING REVIEWED THE INCIDENT INFO. BASED ON THE DEVICE HISTORY RECORDS, THE DEVICE WAS IN WORKING ORDER AND LEFT ABBOTT VASCULAR INSTRUMENTS GMBH IN RANGENDINGEN AS PER SPECIFICATIONS. ALL SAMPLES PASSED THE IN-PROCESS CONTROLS DURING MFR OF THE DEVICES. IT IS REPORTED THAT THE PT CODED IN CCU SHORTLY AFTER TRANSFER FROM THE CATHETER LAB AND EXPIRED SHORTLY AFTERWARDS. NO INFO REGARDING THE PROCEDURE WAS PROVIDED. NO DEVICE MALFUNCTION IS IDENTIFIED IN THE COMPLAINT DESCRIPTION; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF THE GRAFTMASTER STENT CAUSED OR CONTRIBUTED TO THE PT'S DEATH.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: DEATH. DEVICE ISSUE: NONE. IT WAS REPORTED THAT PT CODED IN THE CARDIAC CARE UNIT (CCU) SHORTLY AFTER TRANSFER FROM THE CARDIAC CATH LAB AND EXPIRED SHORTLY AFTERWARDS. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 348101

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death