BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM-HYDRO

    MDR report key: 1953509 · Received January 5, 2011

    Report

    Report Number
    2953200-2011-00010
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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: (ARTERIAL AND VENOUS OCCLUSION) (SEVERELY DISEASED, SEVERELY CALCIFIED AND MODERATE TORTUOSITY). EVALUATION, CONCLUSIONS: (SEVERELY DISEASED, SEVERELY CALCIFIED AND MODERATE TORTUOSITY).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS BEING TREATED FOR A 3.3 CM ILIAC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS SEVERELY DISEASED, SEVERELY CALCIFIED AND MODERATE TORTUOSITY. THE PHYSICIAN IMPLANTED A BIFURCATED STENT GRAFT AND ONE ILIAC EXTENSION ON THE RIGHT SIDE, AND ONE ILIAC LIMB ON THE LEFT SIDE. THE FINAL ANGIOGRAM WAS SUCCESSFUL. IT WAS REPORTED 5 HOURS POST IMPLANT THE PATIENT HAD PAIN IN THE RIGHT LEG. THE CT DEMONSTRATED THAT THERE WAS OCCLUSION OF THE RIGHT ILIAC LIMB. (MFR 2953200-2011-00011). THE OCCLUSION COVERED THE ILIAC EXTENSION AND PART OF THE IPSILATERAL LIMB. THE PHYSICIAN PERFORMED A THROMBECTOMY AND IMPLANTED A VIABAHN STENT. THE OCCLUSION 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-HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00523704

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention