BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 402921 · Received July 3, 2002

    Report

    Report Number
    2952368-2002-00169
    Event Type
    Injury
    Date Received
    July 3, 2002
    Date of Event
    May 24, 2002
    Report Date
    June 5, 2002
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 24MM DIAMETER X 4MM DIAMETER X 13.5CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN 2001. ANEURYSM AND VESSEL MORPHOLOGY ARE UNK. IT WAS REPORTED THAT FOLLOW-UP COMPUTERIZED TOMOGRAPHY (CT) SCANS WERE PERFORMED IN 05/2001, 08/2001, AND 11/2001. THE RESULTS OF THE CT SCANS ARE UNK. A SLIGHT TYPE I LEAK WAS BEING WATCHED BY THE PHYSICIAN BUT IT WAS REPORTED TO HAVE RESOLVED. IT WAS REPORTED THAT A CT SCAN PERFORMED IN 2002 DEMONSTRATED THAT THE DEVICE HAD DISLODGED AND MIGRATED INTO THE ANEURYSM SAC. A TALENT CUFF WAS REQUESTED. IT WAS REPORTED THAT 4 DAYS LATER THE ANEURYSM RUPTURED, AND THE PT WAS CONVERTED TO OPEN SURGICAL REPAIR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. IT WAS REPORTED THAT THE PT IS DOING WELL POST-CONVERSION BUT REMAINS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIVISION NA M01C750463

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention