BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYDRO

    MDR report key: 1053605 · Received May 23, 2008

    Report

    Report Number
    2953200-2008-00364
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (REQUIRED SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE RIGHT HYPOGASTRIC ARTERY WAS PREVIOUSLY OCCLUDED PRIOR TO STENT GRAFT PLACEMENT. IT WAS REPORTED THE IPSILATERAL STENT GRAFT COVERED THE LEFT HYPOGASTRIC ARTERY. THE PHYSICIAN ELECTED TO PERFORM A FEMORAL RETROPERITONEAL CUT DOWN. THE PHYSICIAN CUT OFF AND REMOVED APPROX 1 CM OF THE STENT GRAFT, WHICH WAS COVERING THE LEFT HYPOGASTRIC ARTERY. THE BLOOD FLOW WAS TO THE HYPOGASTRIC ARTERY WAS GOOD. NO ADDITIONAL 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 V00077174

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention