BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT WITH XCELERANT

    MDR report key: 2133507 · Received June 15, 2011

    Report

    Report Number
    2953200-2011-01155
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    June 16, 2010
    Report Date
    May 19, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ARTERIAL AND VENOUS OCCLUSION. RESULTS/CONCLUSIONS: MODERATE TORTUOSITY AND MURAL THROMBUS IN THE ANEURYSM NECK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR/PENETRATING ARTHEROSCLEROTIC ULCER APPROXIMATELY 13 MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTA HAS MODERATE TORTUOSITY, NO CALCIFICATION AND MURAL THROMBUS IN THE ANEURYSM NECK. THE STENT GRAFT DELIVERY SYSTEM WAS ADVANCED THROUGH CONDUIT AND THE FIRST STENT GRAFT WAS IMPLANTED IN ZONE TWO, THE SECOND AND THIRD DEVICES WERE IMPLANTED IN ZONE FOUR WITHOUT ISSUE. A RECENT CT PERFORMED THAT DEMONSTRATED THAT THERE WAS STENT GRAFT THROMBOSIS AND STENT GRAFT STENOSIS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. (REF MFR# 2953200-2011-01153, AND 2953200-2011-01154).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT WITH XCELERANT MIH MEDTRONIC IRELAND NA V00434701

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR