BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH AAA MAIN BODY

    MDR report key: 498421 · Received November 24, 2003

    Report

    Report Number
    1820334-2003-00268
    Event Type
    Other
    Date Received
    November 24, 2003
    Date of Event
    July 10, 2003
    Report Date
    November 18, 2003
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER PLACEMENT OF THE THREE-PIECE MODULAR SYSTEM, POST ANGIOGRAM NOTED A PROXIMAL TYPE I ENDOLEAK. IT APPEARED THAT THE MAIN BODY GRAFT HAD LANDED A LITTLE LOW FROM THE DESIRED LOCATION. THE MAIN BODY EXTENSION WAS EXTENDED THREE MILLIMETERS INSIDE THE MAIN BODY GRAFT IN ORDER TO PROVIDE ADDITIONAL COVERAGE AT THE PROXIMAL SEALING STENT. GOOD PLACEMENT, ENDOLEAK RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA MAIN BODY ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA 1240609

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other