BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX

    MDR report key: 704608 · Received April 20, 2006

    Report

    Report Number
    704608
    Event Type
    Injury
    Date Received
    April 20, 2006
    Date of Event
    April 7, 2006
    Report Date
    April 17, 2006
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, THE INTRODUCER MECHANISM FOR THE ENDOVASCULAR STENT BECAME DISRUPTED AND LODGED IN THE RIGHT COMMON FEMORAL ARTERY. HEMORRHAGE FROM ARTERY AT THE SITE OF INSERTOR. EMERGENT EXPLORATION AND RETRIEVED OF THE FOREIGN BODY IWTH REPAIR OF THE FEMORAL ARTERY WAS REQUIRED. FB RETRIEVED IN RIGHT EXTERNAL ILIAC ARTERY. FB RETRIEVED IN RIGHT EXTERNAL ILIAC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOGIX ENDOVASCULAR INTRODUCER AAA-STENT GRAFT DELIVERY SYSTEM MIH ENDOLOGIX INC. 28-16-140BL W06-0089

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R