BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1870939 · Received October 8, 2010

    Report

    Report Number
    2953200-2010-01912
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    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). EVALUATION RESULTS AND CONCLUSION: (MIGRATION, ENDOLEAK), (DISEASE PROGRESSION WITH AORTIC NECK DILATATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.9 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 21 MONTHS AGO. THE VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS REPORTED AS MODERATE TORTUOSITY, NO CALCIFICATION, THE AORTIC NECK WAS 23 MM IN DIAMETER AND 5.5 CM IN LENGTH. A RECENT CT DEMONSTRATED THAT THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATATION, CURRENTLY THE AORTIC NECK IS 25 MM IN DIAMETER. IT WAS REPORTED THAT THE STENT GRAFT HAS MIGRATED WITH A TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A 28 ANEURX CUFF AND A 30 MM TALENT AORTIC CUFF AND THE STENT GRAFT MIGRATION AND ENDOLEAK WERE RESOLVED. NO ADDITIONAL CLINICAL 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 V00075892

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention