BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFRARENAL BIFURCATED STENT GRAFT

    MDR report key: 3961060 · Received July 23, 2014

    Report

    Report Number
    MW5037435
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ENDOLOGIX
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN EVAR PROCEDURE USING AN ENDOLOGIX DEVICE (STENT GRAFT) A PORTION OF THE UNSHEATHING SECTION WAS FOUND INSIDE THE SHEATH CATHETER. THIS WAS REMOVED IN TOTAL WHEN THE SHEATH WAS REMOVED. AFTER UNVEILING THE GRAFT THE CARRIER SYSTEM IS FROM THE PROTECTIVE SHEATH. AFTER COMPLETION OF THE PROCEDURE THE SHEATH SYSTEM IS REMOVED, THE VESSEL CLAMPED AND THEN REPAIRED. WHEN THE SURGEON REMOVED THE PROTECTIVE SHEATH A PORTION OF WHAT APPEARED TO BE THE UNSHEATHING DEVICE OF THE GRAFT WAS FOUND ATTACHED TO THE SHEATH. IT CAME OUT IN ITS ENTIRETY AND THE VESSEL WAS COMPLETED PROTECTED. THIS APPEARS TO BE A DESIGN FLAW IN THE UNSHEATHING AND WAS REPORTED IMMEDIATELY TO THE VENDOR REP WHO WAS PRESENT DURING THE ENTIRE PROCEDURE. THERE WAS NO HARM TO THE PT AND EVEN COMPLETION XRAYS WERE OBTAINED. THE PT LEFT THE ROOM WITH NORMAL PULSATIONS, A SUCCESSFUL EXCLUSION OF HIS AAA, AND HEMODYNAMICALLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432086 INFRARENAL BIFURCATED STENT GRAFT BIFURCATED STENT GRAFT DSY ENDOLOGIX BA25-100/I16-40 1054881-002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention