BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT XCELERANT STENT GRAFT SYSTEM

    MDR report key: 1870940 · Received October 8, 2010

    Report

    Report Number
    2953200-2010-01913
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY AT THE TIME OF IMPLANTATION AND CURRENTLY WERE NOT REPORTED. A RECENT CT DEMONSTRATED A TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A MEDTRONIC DEVICE THAT IS NOT APPROVED IN THE UNITED STATES AND THE TYPE I ENDOLEAK 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 XCELERANT STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention