BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 3143348 · Received June 3, 2013

    Report

    Report Number
    3005099803-2013-04593
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 10, 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 PRIOR TO THE EXPIRATION DATE. 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 SIGMOID COLON OF A PATIENT ON (B)(6) 2013 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS TREATMENT FOR A MALIGNANT STRICTURE WITHIN THE SIGMOID COLON. DUE TO PERITONEAL DISSEMINATION OF PANCREATIC CANCER. THE STRICTURE WAS 5 CM IN SIZE. DURING THE STENT PLACEMENT PROCEDURE, THE STENT WAS SUCCESSFULLY PLACED WITHOUT ISSUE. FOUR HOURS POST PROCEDURE THE PATIENT WENT INTO ACUTE SHOCK AND PASSED AWAY. A CT SCAN WAS PERFORMED AND CONFIRMED THAT A PERFORATION DID NOT OCCUR. IN THE PHYSICIAN'S ASSESSMENT THE PATIENTS DEATH COULD BE DUE TO INFECTION THAT MAY HAVE OCCURRED DUE TO BACTERIAL INVASION INTO TUMOR VESSEL DURING NORMAL EXPANSION OF THE STENT, AND SEPTICEMIA MAY HAVE DEVELOPED. THERE WAS NO ALLEGED MALFUNCTION OF THE STENT. AN AUTOPSY WILL NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245117 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565110

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death