BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    MDR report key: 1220458 · Received November 4, 2008

    Report

    Report Number
    3005099803-2008-05920
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    ESW
    PMA / PMN Number
    K032930
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST AN ESOPHAGEAL STENT PLACEMENT, A STENT MIGRATION OCCURRED. AN 18X12 ULTRAFLEX ESOPHAGEAL STENT WAS PLACED IN THE ESOPHAGUS. FOUR MONTHS LATER, THE PT PRESENTED WITH DYSPHASIA AND UPON EXAMINATION, IT WAS DISCOVERED THAT THE STENT HAD MIGRATED TO THE STOMACH. THE PHYSICIAN DILATED THE STRICTURE AND THE STENT WAS REMOVED THROUGH THE ESOPHAGUS WITH A SNARE. ANOTHER 18X12 STENT WAS PLACED. NO FURTHER PT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED NG ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC M00513740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention