BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 621332 · Received July 15, 2005

    Report

    Report Number
    2953200-2005-01175
    Event Type
    Injury
    Date Received
    July 15, 2005
    Date of Event
    January 24, 2005
    Report Date
    January 27, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 13.5 CM ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. 37 MONTHS POST STENT GRAFT IMPLANTATION A REQUEST FOR A TALENT AORTIC CUFF UNDER IDE (G020050) WAS REQUESTED. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE AORTIC NECK HAD EXPANDED TO 30 MM, WHICH HAS RESULTED IN THE MIGRATION OF THE STENT GRAFT. THE PT HAS MULTIPLE CO-MORBIDITIES, WHICH DID NOT MAKE THEM A CANDIDATE FOR OPEN SURGICAL REPAIR. A TALENT CUFF WAS REQUESTED AND IMPLANTED 1 MONTH AFTER THE MIGRATION WAS DETECTED. THE PATIENT WAS REPORTED TO BE FINE AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA M01J750897

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention