BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2202049 · Received August 5, 2011

    Report

    Report Number
    2953200-2011-01400
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 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: (ANEURYSM ENLARGEMENT, GRAFT MIGRATION).

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 5 YEARS AGO. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT IS UNKNOWN. THE PATIENT HAS BEEN LOST TO FOLLOW-UP. IT WAS REPORTED THAT APPROXIMATELY 1 MONTH AGO, THE BIFURCATED STENT GRAFT WAS FOUND TO HAVE MIGRATED 5 - 6 CM DISTALLY; HOWEVER, NO ENDOLEAK WAS EVIDENT. AT THE TIME OF MIGRATION, THE ANEURYSM MEASURED 10 CM. THE CAUSE OF THE STENT GRAFT MIGRATION IS UNKNOWN. SEVERAL WEEKS LATER, THE PHYSICIAN ELECTED TO INTERVENE BY SUCCESSFULLY PLACING A 28X28X40 ANEURX CUFF AND A 36X36X70 ENDURANT CUFF. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA B08421

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention