BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 621337 · Received July 15, 2005

    Report

    Report Number
    2953200-2005-01189
    Event Type
    Injury
    Date Received
    July 15, 2005
    Date of Event
    February 2, 2005
    Report Date
    February 2, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PT'S ARTERIES WERE MODERATE TORTUOSITY WITH NO CALCIFICATION. THE PT IS NOT A SURGICAL CANDIDATE DUE TO PT'S AGE, HEALTH STATUS AND CO-MORBIDITIES. IT WAS REPORTED THAT 14 MONTHS POST STENT GRAFT IMPLANTATION A REQUEST FOR A TALENT AORTIC CUFF UNDER IDE (G020050) WAS REQUESTED. THE CT DEMONSTRATED THAT THE STENT GRAFT HAD MIGRATED 5 MM RESULTING IN A TYPE I ENDOLEAK. THERE WAS NO FURTHER INFORMATION PROVIDED TO MEDTRONIC ABOUT THE REQUEST FOR THE DEVICE OR THE DETAILS OF THE PT RELATING TO THE ANEURX DEVICE.

    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 M03L552445

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention