BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1833605 · Received September 8, 2010

    Report

    Report Number
    2953200-2010-01711
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 10, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: (UNKNOWN INDICATION FOR INITIAL IMPLANTATION; UNKNOWN CAUSE OF GRAFT EROSION THROUGH THE AORTA).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM (MFR REPORT # 2953200-2010-01712) WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN INDICATION APPROXIMATELY 16 MONTHS AGO. THE THORACIC AORTA AND ILIAC VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT APPROXIMATELY 1 MONTH AGO, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS COUGHING UP BLOOD. A SECONDARY INTERVENTION WAS PERFORMED AT ANOTHER HOSPITAL, IN WHICH THE GRAFTS MAY HAVE BEEN RELINED WITH ANOTHER MANUFACTURER'S GRAFT. THE STENT GRAFTS MAY HAVE ERODED THROUGH THE AORTA. NO FURTHER INFORMATION HAS BEEN PROVIDED, AND THE PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00288175

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention