BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1870931 · Received October 7, 2010

    Report

    Report Number
    2953200-2010-01898
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: MIGRATION, ENDOLEAK. DISEASE PROGRESSION WITH AORTIC NECK DILATATION. CONCLUSION: DISEASE PROGRESSION WITH AORTIC NECK DILATATION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 45 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNKNOWN. IT WAS CURRENTLY REPORTED THAT AT THE TIME OF IMPLANT, THE STENT GRAFT WAS PLACED LOWER THAN INTENDED AND AN AORTIC CUFF WAS IMPLANTED PROXIMALLY. THE CURRENT VESSEL MORPHOLOGY WAS REPORTED AS 20 DEGREE ANTERIOR AORTIC NECK ANGULATION, THE AORTIC NECK IS 20 MM IN DIAMETER AT THE RENAL ARTERY, 15 MM BELOW THE RENAL ARTERIES 25 MM IN DIAMETER, AND THE AORTIC NECK IS SHAPED IN A REVERSE FUNNEL. THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATATION. CURRENTLY, THE ANEURYSM IS 5.8 CM IN DIAMETER. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED THAT THE AORTIC CUFF AND THE BIFURCATED STENT GRAFT HAVE MIGRATED TOGETHER 20 MM DISTALLY, RESULTING IN A TYPE I ENDOLEAK. (MFR # 2953200-2010-01898 AND MFR # 2953200-2010-01899). THE PHYSICIAN TREATED THE PATIENT WITH A 30 TALENT AORTIC CUFF AND THE STENT GRAFT MIGRATION AND THE ENDOLEAK WERE RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA A63693

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention