BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM- HYDRO

    MDR report key: 1953510 · Received January 5, 2011

    Report

    Report Number
    2953200-2011-00008
    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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (MODERATE STENOSIS, MILD CALCIFICATION AND SEVERE TORTUOSITY) (ARTERIAL AND VENOUS OCCLUSION). EVALUATION, CONCLUSION: (MODERATE STENOSIS, MILD CALCIFICATION AND SEVERE TORTUOSITY).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS SUCCESSFULLY IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM WAS 4.4 CM IN DIAMETER AND THE AORTIC NECK WAS 5 CM IN LENGTH. THE VESSEL MORPHOLOGY WAS REPORTED AS MODERATE STENOSIS THAT WAS BALLOONED PRIOR TO STENT GRAFT IMPLANT, MILD CALCIFICATION AND SEVERE TORTUOSITY. THE PATIENT PRESENTED EMERGENTLY 14 DAYS POST INITIAL IMPLANT WITH LEG PAIN. THE ANGIOGRAM DEMONSTRATED THAT THE IPSILATERAL LIMB (UP TO FLOW DIVIDER) AND EXTENSION LIMB WERE OCCLUDED WITH THROMBOSIS (MFR 2953200-2011-00009). THE PHYSICIAN PERFORMED A FEMORAL TO FEMORAL BYPASS DUE TO THE SEVERE TORTUOSITY OF THE VESSEL. 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 V00536868

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention