BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 516292 · Received January 26, 2004

    Report

    Report Number
    1820334-2004-00043
    Event Type
    Other
    Date Received
    January 26, 2004
    Date of Event
    December 10, 2003
    Report Date
    January 5, 2004
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PLACEMENT OF THE THREE-PIECE MODULAR GRAFT WENT WITHOUT INCIDENT. HOWEVER, DURING THE POST ANGIOGRAM THERE WAS A NOTED DISSECTION NEAR THE DISTAL END OF THE LIMB. ALTHOUGH THE DISSECTION WAS SMALL, THE PHYSICIAN FELT THERE WAS A NEED TO PROVIDE ADDITIONAL COVERAGE AT THE SITE IN ORDER TO PRECLUDE FUTURE INTERVENTION. PLACEMENT WAS SUCCESSFUL. NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT ENDOVASCULAR GRAFT MIH COOK, INC. NA 1293067

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other