BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL COLONIC STENT

    MDR report key: 1062950 · Received June 19, 2008

    Report

    Report Number
    3005099803-2008-00807
    Event Type
    Injury
    Date Received
    June 19, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MFR DATE IS UNK SINCE THE UPN AND LOT NUMBER WERE NOT ASCERTAINABLE FROM THE COMPLAINANT. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. THE MAY 2008, 15-MONTH WALLFLEX ENTERAL COLONIC STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: EVENT DATE IS UNK. ON MAY 22, 2008, A BOSTON SCIENTIFIC EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "WALLFLEX COLONIC STENT PLACEMENT FOR MGMT OF MALIGNANT COLONIC OBSTRUCTION: A PROSPECTIVE STUDY AT TWO CENTERS", PUBLISHED IN GASTROINTESTINAL ENDOSCOPY 67:2008, PP77-84 (SEE ATTACHED). THE STUDY EVALUATED THE EFFECTIVENESS AND SAFETY OF THE WALLFLEX STENT IN TREATING MALIGNANT COLON OBSTRUCTION. THE FOLLOWING INFO WAS DERIVED FROM THIS ARTICLE: THE PT DEVELOPED MINOR RECTAL BLEEDING AFTER 8 DAYS THAT DID NOT NECESSITATE A BLOOD TRANSFUSION AND RESOLVED UNDER MEDICAL THERAPY WITHIN 3 WEEKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention