BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 3143323 · Received June 3, 2013

    Report

    Report Number
    3005099803-2013-04433
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED ISSUE OF STENT FAILED TO EXPAND. 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 PALLIATIVE TREATMENT FOR A STRICTURE DUE TO PERITONEAL DISSEMINATION OF PANCREATIC CANCER. THE MALIGNANT STRICTURE WAS 8 CM IN LENGTH. THE PATIENT'S ANATOMY WAS REPORTED TO BE SEVERELY TORTUOUS. PRIOR TO THE PROCEDURE, THE PATIENT WAS RECEIVING CHEMOTHERAPY(GEMZAR). AFTER THE PROCEDURE, THE PATIENT DID NOT RECEIVE CHEMOTHERAPY OR RADIOTHERAPY. ON (B)(6) 2013, A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED WITHIN THE SIGMOID COLON. AFTER THE STENT WAS DEPLOYED, IT WAS NOTED THAT THE MIDDLE PORTION OF THE STENT DID NOT FULLY EXPANDED. THEREFORE, THE STENT WAS DILATED AND IT SUCCESSFULLY EXPANDED. POST PROCEDURE, ON (B)(6) 2013, THE PATIENT DEVELOPED A FEVER. ON (B)(6) 2013, A CT SCAN WAS PERFORMED AND A PERFORATION WAS NOTED. ON (B)(6) 2013, ABDOMINAL CAVITY DRAINAGE WAS PERFORMED. ON (B)(6) 2013, THE PATIENT DEVELOPED ELEVATED BLOOD PRESSURE. IT WAS ASSUMED THAT A PERFORATING HAD OCCURRED AND THAT THE PATIENT HAD GENERALIZED PERITONITIS AT THIS POINT. THE PATIENT BECAME "SHOCK VITAL". ON THE MORNING OF (B)(6) 2013, THE PATIENT PAST AWAY. AN AUTOPSY WAS PERFORMED AND A PERFORATION, APPROXIMATELY 2CM IN SIZE, WAS FOUND AT THE DISTAL EDGE OF STENT. IN THE PHYSICIAN'S ASSESSMENT, THE STENT WAS DEPLOYED IN AN ANATOMY WHICH WAS SEVERELY TORTUOUS AND THIS MIGHT HAVE CONTRIBUTED TO THE PERFORATION. DURING NORMAL EXPANSION OF THE STENT, THE EDGE OF THE STENT CAUSED THE PERFORATION. POST DILATION OF THE STENT WAS NOT RELATED TO THE PERFORATION. IN THE PHYSICIAN¿S ASSESSMENT, THE PATIENT PASSED AWAY DUE TO ¿PERFORATIVE PERITONITIS¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245084 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565120 15360071

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| R