BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX¿ COLONIC

    MDR report key: 2880103 · Received December 19, 2012

    Report

    Report Number
    3005099803-2012-06057
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 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 WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. PERFORATION AND INFECTION 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 DURING A COLON STENTING PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS PALLIATIVE TREATMENT FOR THE STENOSIS CAUSED BY LARGE INTESTINE MALIGNANCY. THE SIZE OF THE LESION WAS APPROXIMATELY 6 CM IN LENGTH. DURING THE PROCEDURE, THE STENT WAS PLACED IN THE AREA OF THE TRANSVERSE COLON TO THE SPLENIC FLEXURE WITH NO ISSUES ON (B)(6) 2012. ON (B)(6) 2012 AN ABSCESS WAS CONFIRMED VIA CT SCAN NEAR THE SPLENIC FLEXURE. THE ABSCESS WAS REPORTED TO BE THE RESULT OF A PERFORATION, WHICH WAS LOCATED IN THE MID-AREA OF THE STENT(IN THE STENOSIS). A DRAINAGE TUBE WAS PLACED AND THE STENT WAS LEFT IMPLANTED. THE PATIENT IS CURRENTLY UNDER FOLLOW-UP, IF THE CONDITION DOES NOT IMPROVE, A STOMA WILL BE PLACED. IN THE PHYSICIANS ASSESSMENT, "IT IS POSSIBLE THAT THE PERFORATION MIGHT BE CAUSED BY EXPANSION OF THE STENT, HOWEVER, THE EXACT CAUSE WAS UNKNOWN."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention