BEUDAMED
    FDA Adverse Event Summary report: N

    AFX ENDOVASCULAR AAA SYSTEM

    MDR report key: 3032676 · Received March 28, 2013

    Report

    Report Number
    MW5029572
    Date Received
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ENODOLOGIX 11 STUDEBAKER
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ENDOLOGIX GRAFT WAS DEPLOYED AND PART OF THE INNER CANNULA BROKE OFF IN THE PT AND BECAME LODGED IN THE LEFT ILIAC. AS A RESULT A COIL EMBOLIZATION WAS REQUIRED. REASON FOR USE: ISCHEMIA LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129564 AFX ENDOVASCULAR AAA SYSTEM INTRODUCER DYB ENODOLOGIX 11 STUDEBAKER 1091330-014
    129621 AFX ENDOVASCULAR AAA SYSTEM STENT GRAFT SYSTEM MIH ENDOLOGIX 11 STUDEBAKER S17-45 1079612-007

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention