BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX¿ COLONIC

    MDR report key: 2841867 · Received November 21, 2012

    Report

    Report Number
    3005099803-2012-05461
    Event Type
    Death
    Date Received
    November 21, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 29, 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 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 CANCER PATIENT ON (B)(6) 2012, DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS FOR PALLIATIVE TREATMENT OF A MALIGNANT STRICTURE. THE STRICTURE WAS APPROXIMATELY 3 CM IN SIZE, LOCATED IN THE TRANSVERSE COLON NEAR THE SPLENIC FLEXURE. THE PATIENT'S ANATOMY WAS REPORTED TO BE TORTUOUS. THE STENT WAS PLACED TO COVER THE TRANSVERSE COLON AND DESCENDING COLON. REPORTEDLY, THE PATIENT WAS NOT UNDERGOING ANY RADIOTHERAPY OR CHEMOTHERAPY. DURING THE STENT PLACEMENT PROCEDURE, ON (B)(6) 2012, THE STENT WAS DEPLOYED SUCCESSFULLY AND THE PATIENT CONDITION WAS REPORTED TO BE "FINE FOR A WHILE." POST PROCEDURE, ON (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN. ON THAT SAME DAY, A CT SCAN WAS PERFORMED, FREE AIR WAS DETECTED AND A PERFORATION SITE WAS VISUALIZED. SUBSEQUENTLY, THE PATIENT DEVELOPED PERITONITIS. THE PATIENT WAS GIVEN PAIN RELIEF MEDICATION; HOWEVER, THE PATIENT'S FAMILY DECLINED ANY FURTHER TREATMENT. ON (B)(6) 2012, THE PATIENT EXPIRED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS PERFORATING PERITONITIS. IN THE PHYSICIAN'S ASSESSMENT, THE PERFORATION RESULTED FROM THE STENT BEING PLACED AT A TORTUOUS LOCATION WHICH MIGHT HAVE CAUSED THE DISTAL END OF THE STENT TO PERFORATE. AN NECROPSY WAS PERFORMED ON (B)(6) 2012, WHICH FOUND THAT "THE DISTAL EDGE OF THE STENT HAD RUPTURED INTO THE INTRAPERITONEAL. THE 13 MM OF THE DISTAL STENT HAD POPPED OUT FROM THE INTESTINAL TRACT INTO THE INTRAPERITONEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX¿ COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565110 15452390

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| R