BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM HYDRO

    MDR report key: 1211074 · Received October 24, 2008

    Report

    Report Number
    2953200-2008-00963
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION - EVAL: RESULTS AND CONCLUSION: - ENDOLEAK, STENT GRAFT WAS INADVERTENTLY PULLED DOWN BY THE USER.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSEL MORPHOLOGY WAS NO CALCIFICATION OR TORTUOSITY. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT WAS PLACED THE PHYSICIAN ELECTED TO MODEL THE STENT GRAFT WITH THE BALLOON AND INADVERTENTLY PULLED THE STENT GRAFT DOWN. THERE WAS A TYPE I ENDOLEAK DETECTED ON THE CARDIOMEMES DEVICE. THE PHYSICIAN ELECTED TO MONITOR THE PT. THE PT WAS SEEN APPROX 2 WEEKS AFTER THE INITIAL IMPLANT AND THE TYPE I ENDOLEAK COULD NOT BE SEEN ON ANGIOGRAM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00164900

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention