BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 3181644 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-05403
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 1, 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

    DEVICE EXPIRATION DATE IS UNKNOWN; HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    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) 2012, DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STENT PLACEMENT WAS A BRIGDE TO SURGERY, TO TREAT STENOSIS CAUSED BY PRIMARY CANCER OF SIGMOID COLON (WITH METASTASIS TO THE LIVER AND LUNG). THE PATIENT'S ANATOMY WAS NOT TORTUOUS. ON (B)(6) 2012, A WALLFLEX ENTERAL COLONIC STENT WAS SUCCESSFULLY IMPLANTED WITHIN THE COLON. THERE WERE NO ISSUES DURING THE PLACEMENT PROCEDURE. THE PATIENT UNDERWENT CHEMOTHERAPY(AVASTIN AND XELOX) 27 DAYS AFTER THE STENT PLACEMENT PROCEDURE; RADIOTHERAPY WAS NOT ADMINISTERED. AT SOME POINT AFTER CHEMOTHERAPY WAS ADMINISTERED, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND WAS TRANSFERRED TO ANOTHER HOSPITAL. A PERFORATION WAS IN THE VICINITY OF THE DISTAL END OF THE STENT. SURGERY WAS PERFORMED TO CREATE AN ARTIFICIAL STOMA AND THE STENT WAS REMOVED. IN THE PHYSICIAN¿S ASSESSMENT, THE SIZE IN THE STENT'S DIAMETER (25MM) AND MAY HAVE AFFECTED THE STRENGTH OF THE STENT¿S AXIAL FORCE. THEREFORE, THE STENT¿S AXIAL FORCE MAY HAVE CONTRIBUTED TO THE PERFORATION. ALSO, THE CHEMOTHERAPY MIGHT ALSO CONTRIBUTE TO THE PERFORATION. THE PATIENT IS CURRENTLY BEING MONITORED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282076 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565050

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention