BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1983092 · Received February 4, 2011

    Report

    Report Number
    2953200-2011-00286
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    September 8, 2010
    Report Date
    January 5, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (LIMB DEPLOYED OUTSIDE THE GATE).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 4 MONTHS AGO. THE ANEURYSM AND VESSELS AT THE TIME OF IMPLANT WERE DESCRIBED AS UNREMARKABLE, WITH NO TORTUOSITY OR CALCIFICATION. IT WAS REPORTED THAT THE CONTRALATERAL LIMB WAS FOUND TO HAVE BEEN DEPLOYED OUTSIDE AND BEHIND THE GATE. THE FINAL ANGIOGRAM SHOWED THAT THE ANEURYSM SAC WAS FILLING. IT IS UNK HOW THE LIMB WAS DEPLOYED OUTSIDE THE GATE. THE PT HAS BEEN DOING FINE SINCE THE TIME OF IMPLANT. THE DECISION WAS MADE TO IMPLANT A TALENT CONVERTER ON THE IPSILATERAL SIDE AND THE CONTRALATERAL SIDE WAS OCCLUDED WITH A TALENT OCCLUDER. A FEM-FEM BYPASS WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. (MFR 2953200-2011-002287).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00210953

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention