BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1083002 · Received July 28, 2008

    Report

    Report Number
    2953200-2008-00605
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 29, 2008
    Report Date
    June 29, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: ENDOLEAK, RUPTURED ANEURYSM. CONCLUSION: DEVELOPMENT OF A PSEUDOANEURYSM.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM OVER 4 YEARS AGO AS PART OF A CLINICAL TRIAL. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ANEURYSM AND VESSEL MORPHOLOGY AT TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THERE WAS A TYPE 1 ENDOLEAK NOTED 3 YEARS POST IMPLANT BUT REFUSED TREATMENT. APPROXIMATELY ONE MONTH AGO, THE PATIENT PRESENTED WITH A LARGE TYPE 1 ENDOLEAK FILLING AN ANEURYSM/PSEUDOANEURYSM WHICH WAS MOST LIKELY COMMUNICATING WITH A CONTAINED RUPTURE OF THE AORTIC ARCH (DESCENDING AORTA). THE PATIENT WAS SURGICALLY TREATED WITH TOTAL AORTIC ARCH RECONSTRUCTION AND DACRON GRAFTS. FOUR TALENT THORACIC STENT GRAFTS WERE ALSO USED TO REPAIR THE TYPE 1 ENDOLEAK AS WELL AS A TYPE 3 ENDOLEAK COMING FROM SEPARATION BETWEEN COMPONENT 1 AND 2. A RELIANT BALLOON WAS USED TO MOLD THE STENT GRAFTS. A COMPLETION THORACIC ANGIOGRAM SUGGESTED THAT THERE WAS NO ENDOLEAK AND EXCELLENT FLOW THROUGH ALL THE GRAFT COMPONENTS. 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 MIH MEDTRONIC CARDIOVASCULAR NA 108021

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention