BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ENTERAL COLONIC STENT

    MDR report key: 862506 · Received June 11, 2007

    Report

    Report Number
    6000050-2007-00072
    Event Type
    Death
    Date Received
    June 11, 2007
    Date of Event
    June 4, 2006
    Report Date
    May 16, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE CAUSE FOR THIS EVENT. THE PURCHASING CUSTOMER IS UNKNOWN, THEREFORE, A CUSTOMER SHIPMENT HISTORY COULD NOT BE PERFORMED AND A POTENTIAL LOT NUMBER COULD NOT BE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. THE APRIL 2007 WALLFLEX ENTERAL SENT 15-MONTH COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; AN INCREASING TREND WAS NOTED THROUGHOUT THE 15-MONTH TIME SPAN. THIS INCREASING TREND IS COINCIDENT WITH INCREASING PRODUCT SALES.

    Description of Event or Problem · 1

    ON MAY 16, 2007, A BOSTON SCIENTIFIC CORPORATION EMPLOYEE BECAME AWARE OF A 2007 DIGESTIVE DISEASE WEEK POSTER PAPER, TITLED "PREMATURE CLOSURE OF THE DUTCH STENT-IN I TRIAL: COLONIC STENTING VS. SURGERY IN LEFT-SIDED COLONIC OBSTRUCTION FOR INCURABLE COLORECTAL CANCER" BY J.E. VAN HOOFT ET AL. THE FOLLOWING INFORMATION WAS DERIVED FROM THAT PAPER. PATIENT: APPROXIMATELY ELEVEN MONTHS AFTER THE PLACEMENT OF A WALLFLEX ENTERAL COLONIC STENT, A "PERFORATION OF A STENTED TUMOR INTO THE BLADDER OCCURRED" AND SURGERY WAS PERFORMED FOR A "CREATION OF A COLOSTOMA." THE PATIENT DIED APPROXIMATELY FOUR MONTHS LATER. THE PHYSICIAN HAD PLACED AN ENTERAL STENT (UNKNOWN) IN 2005, AND A SECOND STENT (WALLFLEX COLONIC) WAS PLACED FIVE MONTHS LATER, DUE TO A "RE-OBSTRUCTION [AT THE] PROXIMAL SIDE [OF THE] ENTERAL STENT." THE PATIENT WAS DISCHARGED HOME THE SAME DAY. THE PERFORATION WAS DIAGNOSED A MONTH BEFORE, AND THE PHYSICIAN PERFORMED THE STOMA SURGERY THE SAME DAY. "INPATIENT HOSPITALIZATION AND IC STAY" WAS REQUIRED. IN 2006, "THE PATIENT DIED ON PROGRESSION OF DISEASE." AUTOPSY RESULTS HAVE BEEN REQUESTED TO NO AVAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT MQR BOSTON SCIENTIFIC CORPORATION M00565040 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death