BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM - COILTRAC

    MDR report key: 1760730 · Received July 15, 2010

    Report

    Report Number
    2953200-2010-01324
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    April 8, 2010
    Report Date
    June 17, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: ENDOLEAK, UNKNOWN CAUSE OF ENDOLEAK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM APPROXIMATELY 63 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT APPROXIMATELY 60 MONTHS POST-IMPLANTATION, THE PATIENT HAD A FOLLOW-UP CT THAT DEMONSTRATED THAT A TYPE III ENDOLEAK (FABRIC TEAR) WAS PRESENT. AT THE LOCATION OF THE TYPE III ENDOLEAK, THE AORTA WAS NON-TORTUOUS AND NON-CALCIFIED. APPROXIMATELY 1 MONTH LATER, THE CT STILL DEMONSTRATED A LARGE TYPE III ENDOLEAK AT OR VERY CLOSE TO THE FIGURE 8 MARKER, WITH ANEURYSM ENLARGEMENT. THE PHYSICIAN ELECTED TO INTERVENE APPROXIMATELY 1 MONTH AFTER THAT BY IMPLANTING A 44 MM X 40 MM TALENT DISTAL MAIN STENT GRAFT, WHICH SUCCESSFULLY RESOLVED THE TYPE III ENDOLEAK. 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 - COILTRAC MIH MEDTRONIC CARDIOVASCULAR NA 66709

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention