BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1822563 · Received August 27, 2010

    Report

    Report Number
    2953200-2010-01649
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 30, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: ARTERIAL AND VENOUS OCCLUSION. MODERATELY TORTUOUS AND MODERATELY CALCIFIED.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF A 4.9 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSELS WERE MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE PT HAD AN ENDARTERECTOMY ON THE LEFT COMMON FEMORAL DISTAL TO THE INSERTION POINT PRIOR TO THE IMPLANTATION OF THE STENT GRAFT. IT WAS REPORTED THAT THE PT RETURNED TO THE OPERATING ROOM LATER IN THE EVENING WITH A COLD RIGHT FOOT. THE CT DEMONSTRATED THAT THE RIGHT ILIAC LIMB WAS OCCLUDED. THE PHYSICIAN USED AN ANGIOJET IN THE ILIAC LIMB AND MODELED WITH A LESS COMPLAINT BALLOON AND AN ENDARTERECTOMY OF THE RIGHT COMMON FEMORAL DISTAL TO THE INSERTION AND THE OCCLUSION WAS RESOLVED. NO INTERVENTION WAS PERFORMED AND NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00383918

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention