BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 505625 · Received January 8, 2004

    Report

    Report Number
    1820334-2004-00020
    Event Type
    Other
    Date Received
    January 8, 2004
    Date of Event
    December 10, 2003
    Report Date
    December 15, 2003
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE MANIPULATION OF THE GREY POSITIONER, IN ORDER TO RE-CAPTURE THE TOP CAP, A NOTED DISCONNECTION WAS VIEWED POST ANGIOGRAM IN THE LOWER EXTREMITY. THE PHYSICIAN HAD ALREADY EXTENDED THE ILIAC LEG GRAFT WITH AN ILIAC LEG EXTENSION IN ORDER TO PROVIDE THE NEEDED COVERAGE AT THE LANDING SITE. AN ILIAC LEG EXTENSION WAS PLACED TO EXTEND THE GAP BETWEEN THE TWO GRAFTS IN THE LOWER EXTREMITY. FINAL ANGIOGRAM SHOWED NO VISIBLE SIGN OF AN ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT ENDOVASCULAR GRAFT MIH COOK, INC. NA 1233551

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other