BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX DUODENAL

    MDR report key: 21212235 · Received January 22, 2025

    Report

    Report Number
    3005099803-2025-00145
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    November 7, 2024
    Report Date
    January 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MUM
    UDI-DI
    08714729456490
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET/510(K): K062750, K201159 - REPORTED HERE AS IT EXCEEDED THE MAXIMUM CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150101 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED TO TREAT A 2 CM MALIGNANT DUODENAL STENOSIS DURING A COLONOSCOPY WITH DUODENAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED IN THE CORRECT LOCATION. HOWEVER, IT WAS REPORTED THAT THE STENT WAS REMOVED FROM THE PATIENT USING RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX DUODENAL STENT. DUE TO THE AMBIGUITY OF THE EVENT, BOSTON SCIENTIFIC CONSIDERED THE WORST-CASE SCENARIO: THE STENT WAS UNABLE TO EXPAND DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683406 WALLFLEX DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC CORPORATION M00565020 0035044960 08714729456490

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention