BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2000378 · Received February 18, 2011

    Report

    Report Number
    2953200-2011-00458
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    November 10, 2010
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (MIGRATION, ENDOLEAK), (TORTUOUS AND ANGULATED AORTIC NECK). CONCLUSION: (TORTUOUS AND ANGULATED AORTIC NECK).

    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 67 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE STENT GRAFT MIGRATED DISTALLY AN UNKNOWN DISTANCE DUE TO TORTUOSITY AND ANGULATION OF THE AORTIC NECK, RESULTING IN A PROXIMAL TYPE 1 ENDOLEAK (SEE MFR # 2953200-2010-02512). AN ANEURX AORTIC CUFF, (REF MFR 2953200-2011-00457) A TALENT CONVERTER AND A TALENT OCCLUDER WERE IMPLANTED ON THREE MONTHS AGO IN AN ATTEMPT TO RESOLVE THE ENDOLEAK; HOWEVER, THE ENDOLEAK WAS STILL PRESENT. THE PATIENT WAS TREATED WITH ANOTHER MANUFACTURER'S AORTIC CUFF, HOWEVER, THE TYPE I ENDOLEAK DID NOT COMPLETELY RESOLVE. THE PATIENT REFUSED FURTHER TREATMENT AND NO FURTHER INTERVENTION HAS BEEN PERFORMED TO DATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00539537

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Congenital Anomaly