BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT

    MDR report key: 1822560 · Received August 27, 2010

    Report

    Report Number
    2953200-2010-01653
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: ENDOLEAK, MIGRATION, DISEASE PROGRESSION, AND SHORT AORTIC NECK. CONCLUSION: DISEASE PROGRESSION, AND SHORT AORTIC NECK.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF A 6 CM ABDOMINAL AORTIC ANEURYSM APPROX 24 MONTHS AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS REPORTED AS THE AORTIC NECK CHANGES FROM 21 MM IN DIAMETER AT THE RENAL ARTERIES AND 30 MM DISTALLY THE DIAMETER IS 29 MM IN DIAMETER. CURRENTLY, THE AORTIC NECK IS SHORT MEASURING 1 - 1.5 CM AND IT WAS FUNNEL SHAPED. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED AND IS 1 CM BELOW THE RENAL ARTERIES WITH A TYPE 1 ENDOLEAK PRESENT. THE PT WILL BE TREATED IN THE NEXT MONTH. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR NA V00113705

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention