BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYDRO

    MDR report key: 1111729 · Received August 14, 2008

    Report

    Report Number
    2953200-2008-00674
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS - OTHER: LACK OF INFO (PENDING RECEIPT OF FILMS FROM THE USER FACILITY); (ENDOLEAK). CONCLUSION - OTHER: LACK OF INFO (PENDING RECEIPT OF FILMS FROM THE USER FACILITY). OTHER: SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSEL MORPHOLOGY WAS REPORTED AS SMALL IN DIAMETER AND CALCIFIED. IT WAS REPORTED UPON THE FINAL ANGIOGRAM RUN IT APPEARED AS THERE MIGHT BE A TYPE III ENDOLEAK WHERE AN AORTIC CUFF SEPARATED FROM THE BIFURCATED STENT GRAFT. THE PHYSICIAN ELECTED TO PLACE ANOTHER MFR'S STENT GRAFT AND THE ENDOLEAK RESOLVED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00087640

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention