BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CONVERTER STENT GRAFT SYSTEM

    MDR report key: 2133483 · Received June 15, 2011

    Report

    Report Number
    2953200-2011-01156
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: MIGRATION. RESULTS/CONCLUSIONS: CONICAL AORTIC NECK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 12 MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS NO TORTUOSITY, NO CALCIFICATION, AND MINIMAL AORTIC NECK ANGULATION WITH A CONICAL AORTIC NECK. THE PATIENT HAD ONLY ONE ILIAC ARTERY. A TALENT CONVERTER ABDOMINAL STENT GRAFT AND A TALENT EXTENSION WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AND A FEMORAL-FEMORAL BYPASS WAS PERFORMED. IT WAS REPORTED THAT RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED APPROXIMATELY 10-15 MM BELOW THE RENAL ARTERIES. THERE IS NO ENDOLEAK AND NO EXPANSION OF THE NECK. THE PATIENT WAS TREATED WITH AN ENDURANT AORTIC CUFF AND THE MIGRATION WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CONVERTER STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00377316

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention