BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT

    MDR report key: 1002148 · Received February 25, 2008

    Report

    Report Number
    3005099803-2008-00208
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 26, 2008
    Report Date
    January 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BALLOON DILATATION IS CONTRAINDICATED, AND CONSTITUTES OFF-LABEL USE OF THE WALLFLEX ENTERAL DUODENAL STENT AND OF THE BOSTON SCIENTIFIC CORP CRE BALLOON. THE WALLFLEX ENTERAL DUODENAL STENT DIRECTIONS FOR USE (DFU) DOCUMENT STATES: "CAUTION: DO NOT DILATE THE STENT AFTER PLACEMENT." AND THE CRE BALLOON DFU DOCUMENT STATES THAT IT IS "INTENDED... TO ENDOSCOPICALLY DILATE STRICTURES... ANY USE OF THIS DEVICE, OTHER THAN THOSE INDICATED... IS NOT RECOMMENDED." THE DEVICE REMAINS IMPLANTED; THEREFORE, A DEVICE ANALYSIS CANNOT BE PERFORMED, AND THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT CANNOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADD'L COMPLAINTS RECORDED FOR THIS LOT. THE JAN 2008 15-MONTH WALLFLEX ENTERAL STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TRENT WAS NOTED.

    Description of Event or Problem · 1

    A WALLFLEX ENTERAL DUODENAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN AN ADULT PT (AGE, GENDER, WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, "... THE DISTAL END OF THE STENT DID NOT EXPAND AS EXPECTED .... THE [PHYSICIAN...] WAITED FOR 5 MIN[S,] HOPING THE STENT END WOULD FURTHER EXPAND. THE [PHYSICIAN] ALSO USED THE GUIDEWIRE TO CONFIRM THAT THE [FAILURE TO EXPAND] WAS NOT DUE TO [THE] STRICTURE ITSELF. THE [PHYSICIAN] THEN DECIDED TO USE [A] CRE BALLOON [BOSTON SCIENTIFIC CORP, MODEL M00558490] TO DO THE POST DILATATION ON THE LOOP END TO MAKE THE DISTAL STENT OPEN. IT WAS NOT ... SUCCESSFUL. THEN [THE PHYSICIAN] USED [A] STONE RETRIEVAL BALLOON [MFR UNK] TO REPEAT THE ... DILATATION... THREE MORE TIMES. THE DISTAL END OF STENT WAS FINALLY OPEN[ED]." CHOLANGIOGRAM CONFIRMED THAT THE DISTAL FLARE HAD OPENED. REPORTEDLY, THE "... PT WAS IN GOOD CONDITION" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT MUM BOSTON SCIENTIFIC IRELAND, LTD. M00565030 11262839

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK