BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1132642 · Received August 22, 2008

    Report

    Report Number
    2953200-2008-00721
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 25, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: (ARTERIAL AND VENOUS OCCLUSION). LACK OF INFO (NO OPERATIVE REPORTS OR FILMS WERE RECEIVED). (REQUIRED SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYS WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM 20 DAYS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE PT PRESENTED WITH DIMINISHED FLOW THROUGH THE NON STENTED RING AREA OF THE BIFURCATED STENT GRAFT. A PALMAZ STENT WAS IMPLANTED AT THE LOCATION OF THE NON STENTED RING AREA AND SUCCESSFULLY RESOLVED THE OCCLUSION. NO ADD'L 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 V00114704

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention