BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH RENU AAA ANCILLARY GRAFT CONVERTER

    MDR report key: 1892371 · Received November 5, 2010

    Report

    Report Number
    1820334-2010-00578
    Event Type
    Death
    Date Received
    November 5, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEATH AND ADDITIONAL SURGERY IS ADDRESSED PER THE PROVIDED IFU. MIGRATION IS ADDRESS PER THE PROVIDED IFU. EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE FREE FLOW STENT DID NOT OPEN PROPERLY WHEN RELEASED, THIS CAUSED THE DELIVERY SYSTEM TO BE ADVANCED AND ALL THE GRAFT MOVED UPWARD. THE TRIGGER SYSTEM WAS BLOCKED SO THE PT HAD TO GO TO SURGERY. SHE DIED 3 DAYS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH RENU AAA ANCILLARY GRAFT CONVERTER MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2541500

    Patients

    Seq Age Sex Outcome Treatment
    1 Death