BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT THORACIC STENT GRAFT

    MDR report key: 1230348 · Received November 7, 2008

    Report

    Report Number
    2953200-2008-01020
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES, RESULTS: LACK OF INFO (DEVICE WAS NOT RETURNED FOR EVAL). (TIGHTNESS IN THE AORTIC ARCH). CONCLUSION: LACK OF INFO (DEVICE WAS NOT RETURNED FOR EVAL). (TIGHTNESS IN THE AORTIC ARCH).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT WAS IMPLANTED IN THE PT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM THORACIC AORTIC ANEURYSM. THE VESSEL MORPHOLOGY IN THE THORACIC ARCH WAS A TIGHT. IT WAS REPORTED THAT THE STENT GRAFT WAS BEING DEPLOYED AT THE LEFT COMMON CAROTID ARTERY WHICH WAS IN THE PROXIMAL PART ODF THE AORTIC ARCH. UPON DEPLOYMENT, THE PHYSICIAN WAS TURNING THE BLUE HANDLE COUNTER CLOCK WISE AND THE STENT GRAFT WAS NOT DEPLOYING. THERE WAS A CLICKING NOISE NOTED WHEN THE HANDLE WAS BEING TURNED. THE PHYSICIAN REPOSITIONED THE DELIVERY CATHETER AND WAS ABLE TO TURN THE HANDLE; HOWEVER, DURING AN ADDITIONAL TURN, THE PHYSICIAN HEARD THE CLICKING NOISE WAITED AND SLIGHTLY MOVED THE DELIVERY CATHETER AND CONTINUED TO DEPLOY THE STENT GRAFT. THE STENT GRAFT WAS CORRECTLY DEPLOYED. NO ADDITIONAL 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 MIH MEDTRONIC CARDIOVASCULAR NA V00168268

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR