BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1202417 · Received October 17, 2008

    Report

    Report Number
    2024168-2008-00973
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT, BASED ON THE REVIEW OF THE LOT HISTORY RECORD, IT CAN BE ASSUMED THAT THE DEVICE WAS IN WORKING ORDER AND LEFT MANUFACTURING FACILITY AS PER SPECIFICATIONS. IT IS POSSIBLE THAT THE STENT GRAFT DID NOT CROSS BECAUSE OF, BUT NOT LIMITED TO, THE FOLLOWING: TORTUOUS ANATOMY, SEVERELY CALCIFIED VESSELS, PRESENCE OF OTHER DEVICES E.G. PREVIOUSLY IMPLANTED STENTS. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THEREFORE, NO COMPLAINT ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: FAILURE TO CROSS WITH A GRAFTMASTER IS AN ISSUE KNOWN TO REQUIRE A SECOND DEVICE OR ADDITIONAL PROCEDURE. DEVICE ISSUE: FAILURE TO CROSS. IT WAS REPORTED THAT THE GRAFTMASTER WAS UNABLE TO CROSS THE LESION AND WAS NOT IMPLANTED. 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 502702

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR