BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1822562 · Received August 27, 2010

    Report

    Report Number
    2953200-2010-01650
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: ARTERIAL TRAUMA/DISSECTION/PERFORATION, ARTERIAL AND VENOUS OCCLUSION; VESSEL DIAMETER. CONCLUSIONS: VESSEL DIAMETER.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.3 CM THORACIC AORTIC ANEURYSM. THE RIGHT ILIAC ARTERY WAS 8.5 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 9 MM IN DIAMETER. THE VESSELS WERE MILDLY TORTUOUS AND MILDLY CALCIFIED. IT WAS REPORTED THAT WHEN THE DISTAL MAIN WAS INSERTED INTO THE PT, IT WOULD NOT TRACK UP THE PT'S ANATOMY AND RESULTED IN A SMALL ILIAC TEAR. THE ILIAC ARTERY WAS REPAIRED WITH A PATCH. THE DELIVERY CATHETER WAS REMOVED FROM THE PT AND ANOTHER DISTAL MAIN WAS USED TO COMPLETE THE CASE. 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 SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00453166

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention