BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX¿ COLONIC

    MDR report key: 2900438 · Received January 7, 2013

    Report

    Report Number
    3005099803-2012-06421
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 14, 2012
    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 PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE ARE UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS 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 DURING A PROCEDURE TO TREAT AN OBSTRUCTION ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS PALLIATIVE TREATMENT FOR AN OBSTRUCTION DUE TO PERITONEAL METASTASIS FROM STOMACH CANCER. THE LESION WAS LOCATED FROM THE SIGMOID COLON TO THE SIGMOID-DESCENDING COLON. THE PATIENT ANATOMY WAS NOTED TO BE TORTUOUS. THE LESION WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE STENT WAS IMPLANTED ON (B)(6) 2012. FOLLOWING THE STENT PLACEMENT, IT WAS REPORTED THAT THE PATIENT UNDERWENT CHEMOTHERAPY (S-1). ON (B)(6) 2012, A PERFORATION WAS DETECTED. SURGERY WAS PERFORMED TO TREAT THE PERFORATION AND A DRAINAGE TUBE WAS IMPLANTED. IN THE PHYSICIAN'S ASSESSMENT, THE PERFORATION WAS CAUSED BY THE STENT; HOWEVER, IT WAS NOTED THAT THE LOCATION OF THE PERFORATION WAS UNABLE TO BE CONFIRMED DUE TO INFILTRATION DURING SURGERY. THE PATIENT CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7028 WALLFLEX¿ COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565050

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention