BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX COLONIC STENT - 25MM X 120MM

    MDR report key: 1061851 · Received June 17, 2008

    Report

    Report Number
    MW5007324
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 31, 2008
    Report Date
    June 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MQR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WALLFLEX COLONIC STENT PLACED FOR PALLIATION OF MALIGNANT COLONIC OBSTRUCTION DUE TO METASTATIC OVARIAN CANCER IN '08 PRESENT WITH PERITONITIS ABOUT 6 WEEKS POST PROCEDURE. LAPAROTOMY NEXT MORNING LEADING TO STENT FOUND TO HAVE ERODED THROUGH THE WALL OF THE SIGMOID/DESCENDING COLON AT THE PROXIMAL EDGE OF THE STENT, PERFORATING COLON, CAUSING PERITONITIS. STENT WAS REMOVED, PERFORATION REPAIRED AND PATIENT GIVEN COLOSTOMY. PATIENT REMAINS INTUBATED IN ICU. A SERIES OF SIMILAR COMPLICATIONS WERE RECENTLY PUBLISHED IN ENDOSCOPY, MARCH 2008; 40:184-191.A SECOND WALLFEX COLONIC PLACED AT RECTOSIGMOID IN 2008. AN ULTRAFLEX COLONIC STENT PLACED RECLOSING SIX WEEKS LATER (NOT TO PROXIMAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX COLONIC STENT - 25MM X 120MM COLONIC STENT (EXPANDABLE METAL) MQR BOSTON SCIENTIFIC 6506 11564492 OR 11539729

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| S