BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 621387 · Received July 15, 2005

    Report

    Report Number
    2953200-2005-01193
    Event Type
    Injury
    Date Received
    July 15, 2005
    Date of Event
    December 20, 2004
    Report Date
    January 24, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 16.5 CM ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. 11 MONTHS POST STENT GRAFT IMPLANTATION A REQUEST FOR A TALENT AORTIC CUFF UNDER IDE (G020050) WAS REQUESTED. VESSEL TORTUOSITY IS UNKNOWN. IT WAS REPORTED THAT THE CT DEMONSTRATED THAT THE STENT GRAFT HAD MIGRATED INTO THE ANEURYSM SAC. DUE TO THE CO-MORBIDITIES THE PT IS NOT A CANDIATE FOR OPEN SURGICAL REPAIR. THE PHYSICIAN REQUESTED TALENT AORTIC CUFF BECAUSE THE PT'S AORTIC NECK WAS TOO LARGE DISTALLY FOR AN APPROPRIATELY SIZED COMMERCIAL AORTIC CUFF. THE TALENT AORTIC CUFF WAS PLACED SUCCESSFULLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA M02K552636

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention