BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1963341 · Received January 14, 2011

    Report

    Report Number
    2953200-2011-00121
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: (ENDOLEAK), (UNK CAUSE OF ENDOLEAK).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYS WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 3 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNK. AT THE 3 MONTH ROUTINE F/U, THE CT SHOWED A TYPE 1 ENDOLEAK AT THE PROXIMAL NECK. THE PT HAS A 1CM NECK. A 30 MM TALENT CUFF WAS PLACED ONE MONTH LATER UP TO THE LEVEL OF THE RENALS, AND A LEFT ACCESSORY RENAL WAS COVERED. A 34 MM TALENT CUFF WAS PLACED TO BRIDGE THE 30 MM PROXIMAL CUFF AND THE 34 MM MAIN BODY. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00180011

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention