BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOLOGIX

    MDR report key: 837458 · Received March 29, 2007

    Report

    Report Number
    837458
    Date Received
    March 29, 2007
    Date of Event
    March 23, 2007
    Report Date
    March 27, 2007
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE ENDOLOGIX GRAFT POWERLINK SYSTEM THAT WAS BEING USED DURING AN ENDOGRAPHIC AAA (ABDOMINAL AORTIC ANEURYSM) BROKE OFF DURING EXTRACTION AND WENT INTO THE THORACIC AORTA, BLOCKING THE LEFT BRACHIAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOGIX STENT, VASCULAR MIH ENDOLOGIX, INC. * W06-1401

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NO OTHER THERAPIES