BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    MDR report key: 1012335 · Received February 12, 2008

    Report

    Report Number
    3005099803-2008-00264
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    ESW
    PMA / PMN Number
    K032910
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED. THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE FEBRUARY 2008 15-MONTH ULTRAFLEX ESOPHAGEAL STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    AN ULTRAFLEX COVERED NG ESOPHAGEAL STENT WAS USED IN STENT PLACEMENT PROCEDURE ON AN FEMALE PATIENT IN 2008. ACCORDING TO THE COMPLAINANT, WHILE RELEASING THE STENT, THE STENT APPEARED TO RESEMBLE A "HELIX. AN X-RAY PICTURE SHOWED A COMPLETE TWISTING OF THE WHOLE STENT. TO CORRECT THE TWISTING, THE STENT WAS PULLED IN THE PROXIMAL DIRECTION. THE DISTAL AREA OF THE TUMOR WAS THEN OUT OF THE STENT BY APPROXIMATELY 1CM." THE PHYSICIAN ATTEMPTED TO EXTRACT THE STENT, BUT "THE PROXIMAL THREAD RIPPED." HOWEVER, THE PHYSICIAN WAS ABLE TO FULLY EXPAND THE STENT USING FORCEPS (DEVICE AND MANUFACTURER UNK). THE PATIENT REMAINED HOSPITALIZED AND A SECOND STENT (DEVICE AND MANUFACTURER UNK) WAS PLACED TWO DAYS LATER "INTO THE FIRST STENT AND OPENED THE DISTAL PART OF THE STENOSIS." AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED NG ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC IRELAND, LTD. M00513730 0011445334

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R