BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY

    MDR report key: 3960817 · Received June 27, 2014

    Report

    Report Number
    9680654-2014-00014
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 26, 2014
    Manufacturer
    WILLIAM A. COOK AUSTRALIA PTY, LTD.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE VALVE ON THE DELIVERY SYSTEM FOR THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY LEAKED. THE PT HAD VERY LITTLE BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375870 ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY NA MIH WILLIAM A. COOK AUSTRALIA PTY, LTD. AC935041

    Patients

    Seq Age Sex Outcome Treatment
    1 NP