BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1905367 · Received November 18, 2010

    Report

    Report Number
    2953200-2010-02271
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    January 8, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: (ARTERIAL TRAUMA/DISSECTION/PERFORATION), (MODERATE CALCIFICATION IN THE ILIAC ARTERY).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR THORACIC AORTIC ANEURYSM AT ZONE 4 APPROX 11 MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED, AS THERE WAS MODERATE CALCIFICATION IN THE ILIAC ARTERY. THE TWO TALENT THORACIC STENT GRAFTS WERE SUCCESSFULLY IMPLANTED AND THE DELIVERY CATHETERS WERE REMOVED WITHOUT ISSUE. IT WAS REPORTED THAT UPON REMOVAL OF THE INTRODUCER SHEATH, THERE WAS A DISSECTION IN THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN IMPLANTED ANOTHER MFR'S STENT WHICH RESOLVED THE DISSECTION. (MFG# 2953200-2010-02272). 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 NA V00147111Y

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention