BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23367695 · Received October 23, 2025

    Report

    Report Number
    3005099803-2025-05489
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    September 30, 2025
    Report Date
    January 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QXH
    UDI-DI
    08714729904540
    PMA / PMN Number
    K150692
    Removal / Correction Number
    3005099803-12192025-004-
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF THE FISTULA WAS CLOSED USING A 13MM CLIP.

    Additional Manufacturer Narrative · 0

    BLOCKS H7 (IF REMEDIAL ACT INIT, TYPE), H9 (CORRECTION/REMOVAL REPORTING #), AND H11 WERE UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON DECEMBER 19, 2025. BLOCKS D2A (COMMON DEVICE NAME) AND D2B (PRO CODE PRODUCT CODE)), BLOCKS E1 (INITIAL REPORTER EMAIL), G4 (PREMARKET / 510(K) #) AND H6 (IMPACT CODE) WERE CORRECTED. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF THE FISTULA WAS CLOSED USING A 13MM CLIP. BLOCK H11: BOSTON SCIENTIFIC IS INITIATING A REMOVAL OF CERTAIN SIZES OF THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM (6MM X 8MM, 8MM X 8MM AND 20MM X 10MM) MANUFACTURED SINCE MARCH 1, 2025. THIS ACTION IS BEING TAKEN DUE TO INCREASED REPORTS OF STENT DEPLOYMENT AND EXPANSION ISSUES WITH THESE CONFIGURATIONS. THESE ISSUES ONLY OCCUR AT THE TIME OF STENT DELIVERY AND ARE EXPECTED TO BE NOTICED BY THE PHYSICIAN. PATIENTS WHO HAVE BEEN TREATED WITH A SUCCESSFULLY IMPLANTED AXIOS STENT SHOULD CONTINUE TO FOLLOW STANDARD OF CARE AND ARE NOT AFFECTED BY THIS ISSUE. A LETTER WAS SENT OUT TO MATERIALS MANAGERS/HEALTH CARE PROFESSIONALS ON (B)(6) 2025 TO IMMEDIATELY STOP FURTHER DISTRIBUTION OR USE OF ANY AFFECTED 6MM X 8MM, 8MM X 8MM AND 20MM X 10MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. THE LETTER INDICATES TO REMOVE THESE DEVICES FROM INVENTORY AND SEGREGATE THEM IN A SECURE LOCATION UNTIL THEY CAN BE RETURNED TO BOSTON SCIENTIFIC. THE REFERENCED AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM MET ALL SPECIFICATIONS PRIOR TO FINAL APPROVAL FOR DISTRIBUTIONS/SALE.

    Description of Event or Problem · 0

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2025-05487 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENTS AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS WERE TO BE IMPLANTED TRANSDUODENAL TO THE BILIARY DUCT TO TREAT A MALIGNANT BILIARY OBSTRUCTION DURING AN ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY (EUS-CDS) BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST AXIOS STENT (SUBJECT OF MANUFACTURER REPORT# 3005099803-2025-05487) DISTAL FLANGE DID NOT OPEN. A SECOND AXIOS STENT (SUBJECT OF THIS REPORT) WAS USED; HOWEVER, THE DISTAL FLANGE DID NOT OPEN AS WELL. THE STENTS WERE REMOVED FULLY COVERED BY THE OUTER SHEATH, AND THE FISTULA WAS CLOSED USING A 13MM CLIP. THE PATIENT SUBSEQUENTLY UNDERWENT PERCUTANEOUS DRAINAGE. A DIFFERENT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2025-05487 AND 3005099803-2025-05489 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENTS AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS WERE TO BE IMPLANTED TRANSDUODENAL TO THE BILIARY DUCT TO TREAT A MALIGNANT BILIARY OBSTRUCTION DURING AN ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY (EUS-CDS) BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST AXIOS STENT (SUBJECT OF MANUFACTURER REPORT# 3005099803-2025-05487) DISTAL FLANGE DID NOT OPEN. A SECOND AXIOS STENT (SUBJECT OF THIS REPORT) WAS USED; HOWEVER, THE DISTAL FLANGE DID NOT OPEN AS WELL. THE STENTS WERE REMOVED FULLY COVERED BY THE OUTER SHEATH, AND THE FISTULA WAS CLOSED USING A 13MM CLIP. THE PATIENT SUBSEQUENTLY UNDERWENT PERCUTANEOUS DRAINAGE. A DIFFERENT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544776 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM QXH BOSTON SCIENTIFIC CORPORATION M00553520 0036717714 08714729904540

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention