BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH COOK, INC.

    MDR report key: 551869 · Received October 22, 2004

    Report

    Report Number
    MW1033661
    Event Type
    Injury
    Date Received
    October 22, 2004
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ZENITH ENDOGRAFT PLACED IN 2003 WITHOUT INCIDENT. AT ONE YEAR FOLLOW UP, CONTRALATERAL LIMB HAD MIGRATED CAUDALLY ONE CM AT OVERLAP WITH MAIN DEVICE. THIS WAS NOT EVIDENT ON SIX MONTH F/U FILMS. PT WAS TREATED WITH ESLE 12-55 LIMB EXTENSION TO INCREASE THE DEVICE OVERLAP, IN 2004. PT HAD NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH COOK, INC. AAA STENT GRAFT MIH COOK, INC. * 1260957
    2 ZENITH COOK INC. AAA STENT GRAFT MIH COOK INC * 1240587
    3 ZENITH COOK INC AAA STENT GRAFT MIH COOK INC * 1233606

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention