BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2133412 · Received June 14, 2011

    Report

    Report Number
    2953200-2011-01139
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS, CONCLUSION: ANEURYSM ENLARGEMENT. DISEASE PROGRESSION WITH ILIAC VESSEL DILATATION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 6.5 YEARS AGO. ABDOMINAL AORTIC ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. AT THE TIME OF IMPLANT, THE LEFT COMMON ILIAC WAS ANEURYSMAL BUT WAS LEFT UNTREATED IN ORDER TO PRESERVE THE LEFT HYPOGASTRIC ARTERY. IT WAS REPORTED THAT AT THE INITIAL IMPLANT AN ANEURX EXTENSION CUFF WAS THE MOST DISTAL STENT GRAFT ON THE LEFT SIDE. THE LEFT COMMON ILIAC ARTERY HAS CONTINUED TO DILATE AND HAVE DISEASE PROGRESSION DISTAL TO THE STENT GRAFT. NO ENDOLEAK WAS REPORTED. THE PT WILL BE TREATED WITH COILS IN THE LEFT HYPOGASTRIC AND EXTENDING THE ILIAC LIMB DOWN TO THE EXTERNAL ILIAC ARTERY. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA 250592

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention