BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1192571 · Received October 8, 2008

    Report

    Report Number
    2953200-2008-00908
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 17, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: ARTERIAL AND VENOUS OCCLUSION. SEVERE PVD.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 7 WEEKS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT PATIENT PRESENTED WITH BUTTOCK AND HIP CLAUDICATION. THE PHYSICIAN'S IMPRESSION WAS THAT THIS WAS SECONDARY TO A COILED HYPOGASTRIC ARTERY; HOWEVER, UPON FURTHER EVALUATION THE DISTAL END OF THE STENT GRAFT, THE COMMON ILIAC ARTERY AND THE SFA WERE FOUND OCCLUDED. A FEM-FEM AND A FEM-TIBIAL BYPASS WERE SUCCESSFULLY PERFORMED. THIS PATIENT HAD SEVERE PVD WHICH IS THOUGHT TO BE THE CAUSE OF THE VESSEL OCCLUSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00144186

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention