BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX¿ COLONIC

    MDR report key: 2993104 · Received March 7, 2013

    Report

    Report Number
    3005099803-2013-01363
    Event Type
    Death
    Date Received
    March 7, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 14, 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 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. DEATH, PERFORATION AND PERITONITIS ARE LISTED IN THE DFU FOR THIS PRODUCT AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THIS DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED WITHIN THE ASCENDING 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. THE STRICTURE WAS REPORTED TO BE APPROXIMATELY 9 CM IN SIZE. THE PATIENT'S ANATOMY WAS REPORTED TO BE TORTUOUS. ON (B)(6) 2013, A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED WITHIN THE ASCENDING COLON. NO ISSUES WERE REPORTED DURING THE INITIAL STENT PLACEMENT. THE PATIENT RECEIVED CHEMOTHERAPY (AVASTIN) POST STENT PLACEMENT. THE PATIENT HAD A SENSE OF ABDOMINAL DISTENTION, A CT SCAN WAS PERFORMED ON (B)(6) 2013 AND A PERFORATION WAS CONFIRMED. SUBSEQUENTLY, THE PATIENT DEVELOPED PERITONITIS. TREATMENT WAS NOT ADMISTERED FOR THE PERFORATION OR THE PERITONITIS. ON (B)(6) 2013 THE PATIENT PASSED AWAY DUE TO PERFORATIVE PERITONITIS. IN THE PHYSICIAN'S ASSESSMENT, ALTHOUGH THE PERFORATION LOCATION COULD NOT IDENTIFIED, THE PHYSICIAN THINKS THAT THE STENT EDGE MIGHT HAVE CAUSED PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97364 WALLFLEX¿ COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565110 15452389

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death