BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ADVANTAGE BIFURCATED STENT GRAFT - HYDRO

    MDR report key: 1090943 · Received August 1, 2008

    Report

    Report Number
    2953200-2008-00637
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 5, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    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. ANEURYSM MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT UPON POST INTERVENTION CT THE STENT GRAFT WAS COVERING THE RENAL ARTERIES. THE PT IS ON DIALYSIS. THE STENT GRAFT WAS INACCURATELY DELIVERED BY THE USER. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ADVANTAGE BIFURCATED STENT GRAFT - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00114072

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention