BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT

    MDR report key: 1007143 · Received March 5, 2008

    Report

    Report Number
    3005099803-2008-00244
    Event Type
    Injury
    Date Received
    March 5, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A WALLFLEX ENTERAL DUODENAL STENT WAS PLACED (PATIENT AGE, GENDER AND WEIGHT UNK) ON THE MONTH BEFORE. ACCORDING TO THE COMPLAINANT, ONE DAY POST PROCEDURE (THE NEXT DAY), "A PARTIAL DISTAL MIGRATION OF THE ENDOPROSTHESIS WAS DETECTED. IN A SECOND ENDOSCOPIC PROCEDURE ON THREE DAYS LATER, THE MIGRATION WAS MORE EVIDENT." THE PHYSICIAN THEN PLACED A SECOND WALLFLEX ENTERAL DUODENAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT MUM BOSTON SCIENTIFIC IRELAND, LTD M00565020 11115450

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention