BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2210582 · Received August 10, 2011

    Report

    Report Number
    2953200-2011-01402
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: GRAFT MIGRATION, ENDOLEAK. RESULTS/CONCLUSIONS: DISEASE PROGRESSION AND AORTIC NECK DILATATION.

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 46 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. IT WAS REPORTED THAT THE PT WAS BEING EVALUATED FOR KIDNEY STONES, WHEN IT WAS NOTED THAT THE ANEURX BIFURCATED STENT GRAFT HAD MIGRATED DISTALLY AND WAS FOUND TO BE 30 MM BELOW THE RENAL ARTERIES WITH A PROXIMAL TYPE I ENDOLEAK EVIDENT. THE AORTIC NECK HAD 30 TO 40 DEGREE ANGULATION WITH A DIAMETER OF 27 MM PROXIMALLY AND 28 MM DISTALLY. THE STENT GRAFT MIGRATION WAS ATTRIBUTED TO DISEASE PROGRESSION AND AORTIC NECK DILATATION. THE PHYSICIAN ELECTED TO IMPLANT TWO 32 MM ENDURANT CUFFS, WHICH SUCCESSFULLY RESOLVED TO THE ENDOLEAK AND MIGRATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00023073

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention