BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 3192981 · Received June 27, 2013

    Report

    Report Number
    3005099803-2013-05402
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT NOTED THAT THE DEVICE WAS USED NOT PRIOR TO THE EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS A DISPOSED OF; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. PERFORATION IS LISTED IN THE DFU FOR THIS PRODUCT AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THIS DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED WITHIN THE COLON OF A PATIENT ON (B)(6) 2013 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STENT PLACEMENT WAS A BRIDGE TO SURGERY, TO TREAT STENOSIS(TOTAL OCCLUSION) CAUSED BY PRIMARY CANCER OF SIGMOID COLON. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. ON (B)(6) 2013, A WALLFLEX ENTERAL COLONIC STENT WAS SUCCESSFULLY IMPLANTED WITHIN THE COLON. THERE WERE NO ISSUES DURING THE PLACEMENT PROCEDURE. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD POST THE STENT IMPLANT PROCEDURE. ON (B)(6) 2013, THE PLANNED TUMOR RESECTION SURGERY WAS PERFORMED AND AT THAT TIME THE PERFORATION WAS NOTED. THE PERFORATION WAS IN THE VICINITY OF THE PROXIMAL END OF THE STENT. THE PATIENT EXPERIENCED NO PRIOR SYMPTOMS OF THE PERFORATION. DURING THE PLANNED RESECTION SURGERY, THE PERFORATED AREA ALONG WITH THE STENT WERE REMOVED. IN THE PHYSICIAN¿S ASSESSMENT, THE NORMAL AXIAL FORCE OF THE STENT IN COMBINATION WITH BOWEL PERISTALSIS LIKELY CONTRIBUTED TO THE PERFORATION. THE PATIENT CONDITION FOLLOWING THE SURGERY WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294553 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565050

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention