BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 23375882 · Received October 23, 2025

    Report

    Report Number
    3005099803-2025-05635
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    September 30, 2025
    Report Date
    November 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729789796
    PMA / PMN Number
    K240464
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B5 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON OCTOBER 28, 2025. BLOCK H6: IMDRF DEVICE CODE A020602 CAPTURES THE REPORTABLE EVENT OF STENT COVER COMPONENT MISSING. IMDRF PATIENT CODE E1024 CAPTURES THE REPORTABLE EVENT OF BILE PERITONITIS THAT DEVELOPED POST-PROCEDURE. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION TO ADDRESS THE OPEN CBD EXPLORATION.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A020602 CAPTURES THE REPORTABLE EVENT OF STENT COVER COMPONENT MISSING. IMDRF PATIENT CODE E1024 CAPTURES THE REPORTABLE EVENT OF BILE PERITONITIS THAT DEVELOPED POST-PROCEDURE. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION TO ADDRESS THE OPEN CBD EXPLORATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED FROM THE COMMON BILE DUCT TO THE DUODENUM TO TREAT A PERIAMPULLARY CARCINOMA DURING AN ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER THE STENT WAS DEPLOYED, IT WAS OBSERVED THAT THE COVERING PORTION OF THE STENT WAS NOT INTACT. IT WAS NOTED THAT THE COVERING WAS NOT PRESENT ON THE STENT. INITIALLY, THE PHYSICIAN DID NOT REMOVE THE STENT, AS THERE WAS A RISK DUE TO THE OPENING CREATED. HOWEVER, AFTER A PERIOD OF OBSERVATION, THE PATIENT WAS DIAGNOSED WITH BILE PERITONITIS, WHICH NECESSITATED AN OPEN COMMON BILE DUCT (CBD) EXPLORATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 28, 2025. THE OPEN COMMON BILE DUCT (CBD) EXPLORATION PROCEDURE WAS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED TO THE COMMON BILE DUCT TO DUODENUM TO TREAT PERIAMPULLARY CARCINOMA DURING ENDOSCOPIC ULTRASOUND GUIDED CHOLEDECHODUODENOSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, AFTER THE STENT WAS DEPLOYED IT WAS OBSERVED THAT THE COVERING PORTION OF THE STENT WAS NOT INTACT. IT WAS OBSERVED THAT THE COVERING WAS NOT THERE ON THE STENT. INITIALLY, THE PHYSICIAN DID NOT REMOVE THE STENT AS THERE WAS A RISK DUE TO THE OPENING CREATED. HOWEVER, AFTER A PERIOD OF OBSERVATION, THE PATIENT WAS DIAGNOSED WITH BILE PERITONITIS, WHICH NECESSITATED TO HAVE AN OPEN COMMON BILE DUCT (CBD) EXPLORATION. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222514 WALLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00570730 0033738647 08714729789796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention