BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ESPOHAGEAL PARTIALLY COVERED STENT

    MDR report key: 3070281 · Received March 19, 2013

    Report

    Report Number
    3070281
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    July 13, 2012
    Report Date
    August 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC, INC.
    Product Code
    ESW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HERE FOR REMOVAL OF PARTIALLY COVERED ESOPHAGEAL STENT UNDER GENERAL ANESTHESIA. PURSE STRING AT TOP OF STENT BROKE WITH FIRST ATTEMPT TO REMOVE STENT. DR ABLE TO REMOVE BY INVERTING STENT FROM DISTAL END. RESULTED IN LONGER PROCEDURE TIME, PATIENT NEEDING BARIUM SWALLOW TO CHECK FOR PERFORATION, AND THEN ADMIT TO OBSERVE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PATIENT HERE FOR REMOVAL OF PARTIALLY COVERED ESOPHAGEAL STENT UNDER GENERAL ANESTHESIA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115059 WALLFLEX ESPOHAGEAL PARTIALLY COVERED STENT STENT, METALLIC, EXPANDABLE, PARTIALLY COVERED ESOPHAGEAL ESW BOSTON SCIENTIFIC, INC. * 14942230

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR NO OTHER THERAPIES