BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1163586 · Received September 17, 2008

    Report

    Report Number
    2953200-2008-00816
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (REQUIRED SECONDARY INTERVENTION).

    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 2 MONTHS AGO. ANEURYSM MORPHOLOGY WAS NOT REPORTED AND THE ARTERIES WERE NOT TORTUOUS AND HAD SOME CALCIFICATION. IT WAS REPORTED THAT THERE WAS A KINK IN THE DISTAL AORTA. THIS AREA WAS BALLOONED DURING THE PROCEDURE; HOWEVER, THE PT HAD A LIMB OCCLUSION 5 WEEKS POST IMPLANT. A FEM-FEM BYPASS WAS SUCCESSFULLY PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00101844

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention