BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? COLONIC

    MDR report key: 22197609 · Received June 12, 2025

    Report

    Report Number
    3005099803-2025-02692
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    May 23, 2025
    Report Date
    July 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MQR
    UDI-DI
    08714729456582
    PMA / PMN Number
    K201159
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS B5, B7, H6 (PATIENT CODES, IMPACT CODES), AND H11 HAVE BEEN CORRECTED. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF PATIENT CODE E232401 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BOWEL INCONTINENCE. IMDRF IMPACT CODE F2202 CAPTURES THE ENDOSCOPIC PROCEDURE PERFORMED. BLOCK H11: AN AXIOS STENT WAS RECEIVED FOR ANALYSIS; HOWEVER, THE DELIVERY SYSTEM WAS NOT RETURNED. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS FULLY DEPLOYED, WITH NO VISIBLE DAMAGE NOTED. A MEDIA INSPECTION WAS CONDUCTED USING A PHOTO PROVIDED BY THE COMPLAINANT, WHICH INCLUDED A CT SCAN SHOWING THE STENT INSIDE THE PATIENT'S ANATOMY, AS WELL AS SEVERAL IMAGES OF THE STENT OUTSIDE THE PATIENT'S ANATOMY. HOWEVER, THE MEDIA EVIDENCE PROVIDED BY THE CUSTOMER WAS LIMITED AND DID NOT OFFER ANY ADDITIONAL DETAILS RELEVANT TO THE DEVICE ANALYSIS. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED EVENT OF STENT MIGRATION. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THERE IS NO INFORMATION THAT THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU)/ PRODUCT LABEL. ADDITIONALLY, STENT MIGRATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE IN THE MANUFACTURER'S LABELING; THEREFORE, THE MOST PROBABLE ROOT CAUSE IS KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF PATIENT CODE E2324 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BOWEL INCONTINENCE. IMDRF IMPACT CODE F19 CAPTURES THE SURGICAL PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX COLONIC STENT WAS IMPLANTED IN THE RECTOSIGMOID JUNCTION TO TREAT A COLORECTAL TUMOR DURING AN INTESTINAL STENT IMPLANTATION UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2025. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE EVENTS REPORTED. FOLLOWING THE PATIENT'S DISCHARGE ON (B)(6) 2025, SYMPTOMS INDICATING POSSIBLE STENT MIGRATION WERE REPORTED, INCLUDING ABSENCE OF BOWEL MOVEMENT AND SENSATION OF THE STENT AT THE ANUS. IMAGING CONFIRMED THE MIGRATION. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOSCOPIC PROCEDURE TO REMOVE THE MIGRATED STENT AND SUCCESSFULLY IMPLANT A REPLACEMENT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AND WAS DIAGNOSED WITH A COLORECTAL TUMOR WITH INTESTINAL OBSTRUCTION. THE WALLFLEX ENTERAL STENTS WAS IMPLANTED IN THE RECTUM AND SIGMOID JUNCTION TO TREAT A COLORECTAL TUMOR DURING AN INTESTINAL STENT IMPLANTATION UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PROCEDURE PERFORMED ON (B)(6) 2025. POST IMPLANT PROCEDURE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025; HOWEVER, THEY EXPERIENCED BOWEL MOVEMENT FAILURE. THE STENT COULD BE FELT MIGRATED TO THE ANUS. ON (B)(6) 2025, THE PATIENT WAS SENT FOR SURGERY TO REMOVE THE STENT AND PLACE ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033377 WALLFLEX? COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC CORPORATION M00565110 0035044968 08714729456582

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention