BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 3143186 · Received June 3, 2013

    Report

    Report Number
    3005099803-2013-04432
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 28, 2013
    Report Date
    May 8, 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

    PATIENT WEIGHT IS REPORTED TO BE APPROXIMATELY (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED 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) 2013 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, A PREVIOUS SURGERY WAS PERFORMED ON AN UNKNOWN DATE. THE PATIENT UNDERWENT CHEMOTHERAPY (AVASTIN + CAPECITABINE) UP TO 3 WEEKS PRIOR TO THE STENT PLACEMENT PROCEDURE. ONE WEEK BEFORE THE PROCEDURE, PERIODIC EXAMINATIONS WERE PERFORMED AND THE RE-OCCURRENCE OF A CANCEROUS STRICTURE WAS CONFIRMED AT THE ANASTOMOSIS SITE (FROM PREVIOUS SURGERY). THEREFORE, STENT PLACEMENT WAS RECOMMENDED. IF THE RESULT OF THE STENT PLACEMENT WAS GOOD, ANOTHER SURGERY WOULD BE SCHEDULED TO CREATE A STOMA. IT WAS REPORTED THAT THE MALIGNANT STRICTURE WAS 2-3 CM IN LENGTH. 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 WAS NOT ADMINISTERED CHEMOTHERAPY OR RADIATION THERAPY FOLLOWING THE STENT PLACEMENT. TWO DAYS AFTER THE STENT PLACEMENT PROCEDURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN. THEREFORE, A CT SCAN WAS PERFORMED AND FREE AIR WAS FOUND AT THE PROXIMAL END OF THE STENT. A PERFORATION WAS DIAGNOSED IN CLOSE VICINITY OF THE STENT. THE PHYSICIAN ALLEGED NO MALFUNCTION OF THE STENT. A DRAINAGE TUBE WAS PLACED WITHIN THE ABDOMINAL CAVITY AND THE STENT WAS LEFT IMPLANTED. THE PATIENT IS BEING MONITORED AND THE PATIENT¿S CONDITION IS IMPROVING. THE PATIENT IS ABLE TO EAT AND IS NO LONGER COMPLAINING OF PAIN. ALTHOUGH FREE AIR HAS NOT COMPLETELY SUBSIDED, IT HAS IMPROVED. AT THIS TIME THE PHYSICIAN IS NOT PLANNING FURTHER TREATMENT BECAUSE THE PATIENT IS ONLY EXPERIENCING LIMITED PAIN AND THE PRESENCE OF FREE AIR. IN ADDITION, NO BLEEDING WAS NOTED AROUND THE PERFORATION. IN THE PHYSICIAN¿S ASSESSMENT, ANOTHER SURGERY WOULD RISK DAMAGING THE ANASTOMOSIS SITE FROM THE PREVIOUS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245248 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565140 0015210183

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention