BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2080593 · Received April 22, 2011

    Report

    Report Number
    2953200-2011-00869
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    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). EVAL RESULTS AND CONCLUSION: (MIGRATION, ENDOLEAK). (DISEASE PROGRESSION OF THE AORTIC NECK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 4 YRS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. ONE MONTH AGO THE PT PRESENTED WITH SEVERE BACK PAIN. IT WAS REPORTED THAT A CT SCAN WAS PERFORMED AND DEMONSTRATED THAT THE STENT GRAF MIGRATED INTO THE ANEURYSM SAC AND THERE WAS A TYPE I ENDOLEAK PRESENT. THE ANEURYSM DIAMETER IS 5.5 CM. THE VESSELS HAD MILD CALCIFICATION, THE AORTIC NECK WAS SEVERELY TORTUOUS AND THERE WAS DISEASE PROGRESSION. THE AORTIC NECK MEASURED 19 MM AT THE RENAL ARTERIES AND 27 MM IN DIAMETER 2 CM BELOW THE RENAL ARTERIES. A 25X16 MM ENDURANT STENT GRAFT WAS IMPLANTED FOUR DAYS LATER AND SUCCESSFULLY RESOLVED THE ENDOLEAK AND MIGRATION. NO ADD'L CLINICAL SEQUELAE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA 1000384

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention