BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1841187 · Received September 10, 2010

    Report

    Report Number
    2953200-2010-01733
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS - (ARTERIAL AND VENOUS OCCLUSION); (LARGE RIGHT ILIAC ANEURYSM, SEVERELY TORTUOUS ILIAC ARTERIES). CONCLUSION - (LARGE RIGHT ILIAC ANEURYSM, SEVERELY TORTUOUS ILIAC ARTERIES).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS INSERTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD A LARGE RIGHT ILIAC ANEURYSM. THE ILIAC ARTERIES WERE SEVERELY TORTUOUS AND TOOK AN 'S" SHAPE. IT WAS REPORTED THAT AFTER THE STENT GRAFTS WERE IMPLANTED THE RIGHT SIDE WAS FOUND OCCLUDED. THE OCCLUSION WAS DISTAL TO THE LAST ILIAC EXTENSION LIMB ON THE IPSILATERAL SIDE WHICH HAD BEEN EXTENDED WITH 2 ILIAC STENT GRAFTS DUE TO ITS LENGTH AND SIZE. THE OCCLUSION WAS ATTRIBUTED TO THE DISTAL MOST STENT GRAFT WHICH LANDED RIGHT AT ONE OF THE CURVES. THE STENT GRAFT WAS NOT KINKED. A FEM-FEM BYPASS WAS PERFORMED AND SUCCESSFULLY RESOLVED THE OCCLUSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT 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 V00445094

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention