BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL COLONIC STENT

    MDR report key: 1080395 · Received July 22, 2008

    Report

    Report Number
    3005099803-2008-01234
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A COLONIC STENTING TREATMENT PROCEDURE, A PERFORATION WAS DISCOVERED. THE PROCEDURE WAS INDICATED DUE TO A TUMOR IN THE LEFT FLEXURE OF THE COLON. A 30/25X 12 230CM WALLFLEX COLONIC STENT WAS DEPLOYED IN THE TARGET LESION WITH GOOD BORDER FROM THE EDGE OF BOTH SIDES OF THE TUMOR. THE EDGE OF THE STENT WAS NOT IN A CURVE OF THE COLON FLEXURE. THE PHYSICIAN NOTED THAT THE STENT DEPLOYMENT SEEMED "RATHER SLOW" FOR UNSPECIFIED REASONS. SIX DAYS LATER, THE PT RETURNED TO THE HOSPITAL DUE TO ABDOMINAL PAIN AND "VIGOROUS" PERITONITIS WAS DIAGNOSED. THE PT REQUIRED EMERGENCY SURGERY. A SMALL COLONIC PERFORATION IN THE "UPPER PART OF FEMIA LIBERA" AT THE TRANSVERSIUM. THE STENT EDGE HAD PERFORATED THE MUCOSA WITH THE PERFORATION OCCURRING IN A HEALTHY PORTION OF THE COLON. A COLON RESECTION WAS PERFORMED. THERE WERE NO ADDITIONAL PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT MQR BOSTON SCIENTIFIC M00565060

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention