BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1905337 · Received November 18, 2010

    Report

    Report Number
    2953200-2010-02278
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: (ARTERIAL AND VENOUS OCCLUSION), (SEVERELY TORTUOUS VESSELS).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF BILATERAL ILIAC ANEURYSMS. THE ILIAC ARTERIES WERE REPORTED AS SEVERLY TORTUOUS. IT WAS REPORTED A RECENT ULTRA SOUND DEMONSTRATED THAT ILIAC LIMB STENT GRAFTS ARE OCCLUDED. THE PHYSICIAN ASSUMES THAT THE LIMBS KINKED BACK OFF AND CAUSED THE THROMBOSIS, DUE TO THE SEVERE TORTUOSITY OF THE ILIAC LIMBS. THE PHYSICIAN PERFORMED A FEMORAL TO FEMORAL BYPASS AND RESTORED BLOOD FLOW. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. (MFR 2953200-2010-02279).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00422238

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention