BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX AFX ENDOVASCULAR AAA SYSTEM

    MDR report key: 3121787 · Received May 14, 2013

    Report

    Report Number
    MW5030203
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STENT DELIVERY SHEATH
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING VASCULAR SURGERY FOR AORTO-ILIAC OCCLUSIVE DISEASE, THE PLATINUM TIP OF THE DELIVERY SHEATH SHEARED OFF. SURGEON WAS UNABLE TO RETRIEVE AND THE TIP REMAINS LODGED IN A SMALL ILEAL LUMBER VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212475 ENDOLOGIX AFX ENDOVASCULAR AAA SYSTEM STENT DELIVERY SHEATH MIH STENT DELIVERY SHEATH S17-45 1080184-004

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention