BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1905365 · Received November 18, 2010

    Report

    Report Number
    2953200-2010-02273
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    December 3, 2009
    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). EVAL, CONCLUSIONS: (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 47 MM X 50 MM SACCULAR THORACIC AORTIC ANEURYSM AT ZONE 4 APPROX 12 MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS MODERATE CALCIFICATION IN THE ILIAC ARTERY. IT WAS REPORTED THAT AFTER THE INITIAL IMPLANT OF THE TWO TALENT THORACIC STENT GRAFTS, THERE WAS A DISSECTION OF RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN IMPLANTED AN UNK BRAND STENT GRAFT WHICH RESOLVED THE DISSECTION. (MFG# 2953200-2010-02274). 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention