BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1953513 · Received January 5, 2011

    Report

    Report Number
    2953200-2011-00002
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    November 18, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (RESULTS, CONCLUSIONS) - (OTHER): LACK OF INFO (PENDING EXPLANT ANALYSIS).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 3 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THERE IS AN ALLEGED DEVICE FAILURE WHICH LEAD TO AN OPEN AAA REPAIR AND REMOVAL OF DEVICE. THE PT WAS ALIVE AFTER THE EXPLANT PROCEDURE AND THE CURRENT STATUS OF THE PT IS UNK. THE DEVICE HAS BEEN REC'D AND ITS ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00445057

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention