BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH AAA MAIN BODY GRAFT

    MDR report key: 498770 · Received November 25, 2003

    Report

    Report Number
    1820334-2003-00238
    Event Type
    Other
    Date Received
    November 25, 2003
    Date of Event
    October 31, 2003
    Report Date
    October 31, 2003
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A TYPE I PROXIMAL ENDOLEAK WAS NOTED AFTER PLACEMENT OF THE MAIN BODY GRAFT, CONTRALATERAL AND IPSILATERAL ILIAC LEG GRAFTS. THE SITE OF THE PROXIMAL ENDOLEAK WAS RE-BALLOONED WITH THE MOLDING BALLOON, BUT THE ENDOLEAK PERSISTED. ANOTHER MANUFACTURER'S STENT WAS PLACED IN THE PROXIMAL PORTION OF THE STENT GRAFT. UNFORTUNATELY, THE STENTED BALLOON CATHETER HAD A CRACK AT THE SIDEPORT AND THE PHYSICIAN WAS UNABLE TO FULLY INFLATE THE STENT. THE BALLOON WAS WITHDRAWN AND ANOTHER BALLOON WAS INTRODUCED TO COMPLETE THE INFLATION OF THE STENT. WHILE THE STENT WAS PARTIALLY INFLATED, THE STENT MIGRATED SLIGHTLY. THE STENT WAS SEALED AT THE PROXIMAL PORTION OF THE MAIN BODY GRAFT BUT WAS NOW NOT LOCATED HIGH ENOUGH TO SEAL THE ENDOLEAK. ANOTHER STENT WAS INTRODUCED AND PLACED IN THE MOST PROXIMAL PORTION OF THE MAIN BODY GRAFT. PLACEMENT WAS SUCCESSFUL AND THE ENDOLEAK WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA MAIN BODY GRAFT ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA 1259779

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other