BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1241272 · Received November 21, 2008

    Report

    Report Number
    2953200-2008-01089
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 2008
    Manufacturer
    MEDTRONIC CARDIO VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REQUIRED SECONDARY INTERVENTION - RESULTS - STENT GRAFT WAS INADVERTENTLY PULLED BACK. CONCLUSIONS - STENT GRAFT WAS INADVERTENTLY PULLED BACK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIRST PROXIMAL STENT GRAFT WAS INADVERTENTLY PULLED BACK, NECESSITATING ADDITIONAL STENT GRAFTS TO BE USED. THE ANEURYSM WAS SUCCESSFULLY TREATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIO VASCULAR NA V00165927

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention