BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2010914 · Received March 4, 2011

    Report

    Report Number
    2953200-2011-00608
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (MIGRATION, ENDOLEAK); (FUNNEL SHAPED AORTIC NECK); (INCORRECT SIZED STENT GRAFT). CONCLUSION: (FUNNEL SHAPED AORTIC NECK); (INCORRECT SIZED STENT GRAFT).

    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 3 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WAS NOT REPORTED. THE PROXIMAL NECK MEASURED 20-28MM OVER 3 CM BUT A 28 MM ANEURX GRAFT WAS IMPLANTED. THERE WAS A 40 DEGREE ANTERIOR TO POSTERIOR ANGULATION OF THE NECK. THE CURRENT SIZE OF THE AAA IS 6.2 CM. IT WAS REPORTED THAT THE CT SHOWED A PROXIMAL TYPE 1 ENDOLEAK IN ADDITION TO A DISTANCE OF 4 CM FROM THE RENALS TO THE TOP OF GRAFT. TWO ANEURX CUFFS AND ONE ENDURANT CUFF WERE IMPLANTED APPROX 2 WEEKS AGO AND SUCCESSFULLY RESOLVED THE ENDOLEAK AND THE MIGRATION. IT WAS ASSESSED THAT THE MIGRATION MIGHT BE CAUSED BY IMPROPER SIZING OF THE GRAFT AT IMPLANT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00061036

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention