BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? DUODENAL

    MDR report key: 23251444 · Received October 8, 2025

    Report

    Report Number
    3005099803-2025-05130
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    September 2, 2025
    Report Date
    October 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT MATERIAL DEFORMATION. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC PROCEDURE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED TO TREAT DUODENAL ADENOCARCINOMA IN THE DUODENUM DURING A DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT PRESENTED WITH DYSPHAGIA AND WAS SCHEDULED FOR OESOPHAGO-GASTRO-DUODENOSCOPY (OGD). DURING OGD PROCEDURE, THE IMPLANTED STENT WAS OBSERVED TO HAVE STARTED TO SEVERELY DISINTEGRATE AND INTERNAL WIRES OF THE STENT WERE SEEN. THE PHYSICIAN PLACED 2 STENTS BELOW THE ORIGINAL STENT, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663284 WALLFLEX? DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC CORPORATION M00565030 0035387751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention