BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT GRAFT

    MDR report key: 3231833 · Received July 12, 2013

    Report

    Report Number
    1820334-2013-00288
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT AN ABDOMINAL AORTIC ANEURYSM IN 2011 IN (B)(6). ON (B)(6) 2013 THE PATIENT WAS ADMITTED THROUGH ANOTHER FACILITY'S EMERGENCY DEPARTMENT WITH ABDOMINAL PAIN. A CT SCAN WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE A TYPE IA ENDOLEAK. THE PHYSICIAN DECIDED IT WAS SYMPTOMATIC OF THE ENDOLEAK AND REQUIRING IMMEDIATE TREATMENT. THE PATIENT WAS MOVED TO THE OPERATING ROOM WHERE COMPONENTS PLACED BY THE INITIAL PHYSICIAN WERE EXPLANTED AND THE PATIENT WAS SUCCESSFULLY CONVERTED. THE ILIAC GRAFTS WERE NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324727 ZENITH AAA ENDOVASCULAR GRAFT GRAFT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention