BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOLOGIX

    MDR report key: 5917007 · Received August 31, 2016

    Report

    Report Number
    5917007
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    March 26, 2013
    Report Date
    May 13, 2016
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT HAD TWO ENDOLOGICS AORTIC GRAFTS IMPLANTED IN (B)(6) 2013. THE PATIENT RETURNED TO THE OR IN LATE (B)(6) FOR DEVICE EXPLANATION AND OPEN REPAIR OF AORTIC ANEURYSM. IT IS UNKNOWN IF THE DEVICE FAILED, OR IF THE PATIENT'S ANATOMY IMPACTED A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568888 ENDOLOGIX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX BA-2580/I13-40 1047016-005

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR