BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1933728 · Received December 16, 2010

    Report

    Report Number
    2953200-2010-02577
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ARTERIAL TRAUMA/DISSECTION/PERFORATION). EVAL, RESULTS & CONCLUSION: (NARROW CALCIFIED AND STENOTIC ILIAC ARTERIES).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ILIAC ARTERIES WERE CALCIFIED. IT WAS REPORTED THAT AFTER THE STENT GRAFT WAS IMPLANTED, THE PHYSICIAN WAS BALLOONING A STENOTIC PORTION OF THE VESSEL WITH A RELIANT BALLOON WHEN THE ILIAC ARTERY RUPTURED. THE BALLOON WAS COMPLETELY WITHIN THE STENT GRAFT (3 CM WITHIN THE GRAFT). THE RUPTURE WAS ATTRIBUTED TO THE VESSEL CALCIFICATION AS THE BALLOONING WAS NOT AGGRESSIVE (SEE MFR # 2953200-2010-02578). A TALENT ILIAC 14X16X105 WAS PUT IN AND SUCCESSFULLY COVERED / RESOLVED THE RUPTURED ILIAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00494840

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention