BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1833607 · Received September 8, 2010

    Report

    Report Number
    2953200-2010-01709
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS/CONCLUSIONS: ARTERIAL TRAUMA/DISSECTION/PERFORATION. VERY DISEASED SUBCLAVIAN ARTERY. WIRES MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A PENETRATING ULCER IN THE THORACIC AORTIC. THE SUBCLAVIAN ARTERY WAS VERY DISEASED. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS AT THE TIME OF IMPLANT. AFTER THE IMPLANTATION, THE PT DEVELOPED A BLOOD INFUSION IN THE CHEST. A F/U CT WAS PERFORMED AND DEMONSTRATED THAT THE BLOOD WAS COMING FROM AROUND THE SUBCLAVIAN ARTERY. AS THE LOCATION OF THE STENT GRAFT IS 4 TO 5 FROM THE SUBCLAVIAN ARTERY, THERE IS A POSSIBILITY THAT THE WIRES USED DURING THE IMPLANT PROCEDURE MAY HAVE CONTRIBUTED TO THE EVENT. THE PHYSICIAN DECIDED TO INTERVENE BY STENTING THE SUBCLAVIAN ARTERY WITH ANOTHER MANUFACTURER'S STENT SUCCESSFULLY. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00200894

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention