BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1832340 · Received September 3, 2010

    Report

    Report Number
    2953200-2010-01696
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).: RESULTS: (TIGHT AND TORTUOUS ILIAC ARTERIES). CONCLUSIONS: (TIGHT AND TORTUOUS ILIAC ARTERIES).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. THE ILIACS WERE TIGHT AND TORTUOUS. THE THORACIC AORTA WAS LONG AND EXTREMELY TORTUOUS AND MEASURED FROM 29 MM TO 34 MM IN DIAMETER. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO TRACK THE DEVICE UP THROUGH THE VESSELS AND WHEN THE DELIVERY CATHETER WAS REMOVED FROM THE PT THE GRAFT COVER HAD A SEVERE KINK. THE PHYSICIAN WENT IN FROM THE OTHER SIDE WAS ABLE TO INSERT ANOTHER TALENT THORACIC DEVICE AND COMPLETED THE CASE SUCCESSFULLY. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE DELIVERY SYSTEM WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00485738

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR