BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT

    MDR report key: 1000477 · Received February 21, 2008

    Report

    Report Number
    1820334-2008-00102
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 21, 2008
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A FEMALE PATIENT UNDERWENT AAA REPAIR IN 2007, WITH ZENITH DEVICE TO REPAIR ANOTHER MANUFACTURER'S MIGRATED GRAFT. THIS PROCEDURE WAS DONE AS A COMPASSIONATE USE, BECAUSE THE PATIENT WAS OUTSIDE COOK'S INSTRUCTIONS FOR USE. THE PHYSICIAN PLACED A CUFF. AT THE END OF THE PROCEDURE, THERE WAS STILL A SLIGHT ENDOLEAK BUT IT WAS BETTER. AFTER FOLLOW UP CT SCANS, THE PHYSICIAN DECIDED TO PUT IN A 36MM RENU CONVERTER THAT IS NOW AVAILABLE. THIS WAS DONE IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT MIH ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA 1908613

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention