BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1080778 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00586
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, SECONDARY INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM, AN IDE CLINICAL TRIAL DEVICE WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. THE ECTATIC INFRARENAL ABDOMINAL AORTA HAS EXPANDED IN DIAMETER FROM 34 MM TO 37 MM. IT WAS REPORTED APPROXIMATELY 50 MONTHS POST STENT GRAFT IMPLANT THE ANEURYSM SIZE HAS CHANGED FROM 88 MM TO 107 MM. IT WAS REPORTED THAT THE PATIENT PRESENTED ON A RECENT FOLLOW-UP APPROXIMATELY WITH STENT GRAFT MIGRATION, TYPE I ENDOLEAK AND ANEURYSM ENLARGEMENT. THE PHYSICIAN ELECTED TO PLACE A PROXIMAL EXTENSION TO REPAIR THE TYPE I ENDOLEAK. NO ADDITIONAL INFORMATION WAS PROVIDED AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 52736

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention