BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23574427 · Received November 17, 2025

    Report

    Report Number
    3005099803-2025-06122
    Event Type
    Death
    Date Received
    November 17, 2025
    Date of Event
    January 1, 2022
    Report Date
    November 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K233318
    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 D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE UPN AND/OR LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK B3: DATE OF EVENT NOT PROVIDED. HOWEVER, JANUARY 1ST, 2022 WAS SELECTED AS THE ESTIMATED EVENT DATE BECAUSE THE INFORMATION IN THE ARTICLE WAS STUDIED BETWEEN JANUARY 2022 AND JANUARY 2024. BLOCK G2 LITERATURE SOURCE: SRIDHAR SUNDARAM, SUPRABHAT GIRI, BHAVIK SHAH, JIMMY NARAYAK, RADHIKA CHAVA, VISWANATH R. DONAPATI, SHIVAM KHARE, JIJO VARGHESE, BIPADABHANJAN, MALLICK, ADITYA KALE. "REINTERVENTION AFTER ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY FOR DISTAL MALIGNANT BILIARY OBSTRUCTION". SURGICAL LAPAROSCOPY, ENDOSCOPY & PERCUTANEOUS TECHNIQUES (2025;35:E1382). HTTPS://WWW.SURGICAL-LAPAROSCOPY.COM. BLOCK H6: IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING THE HOT AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE TITLED "REINTERVENTION AFTER ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY FOR DISTAL MALIGNANT BILIARY OBSTRUCTION" BY SUPRABHAT GIRI ET AL. THIS MULTICENTER RETROSPECTIVE OBSERVATIONAL STUDY ANALYZED PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION WHO UNDERWENT ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY (EUS-CDS) ACROSS EIGHT TERTIARY CARE CENTERS IN INDIA. A TOTAL OF 134 PATIENTS WERE INCLUDED BETWEEN JANUARY 2022 AND JANUARY 2024. AMONG THEM, SELF-EXPANDING METALLIC STENTS (SEMS) WERE USED IN 118 CASES, AND LUMEN-APPOSING METAL STENTS (LAMS), INCLUDING THE HOT AXIOS, WERE USED IN 16 CASES AS PART OF THE DRAINAGE PROCEDURES. THE ARTICLE DESCRIBED THE PROCEDURAL DETAILS AND THEIR OUTCOMES FOLLOWING EUS-CDS. ONE PATIENT WHO DEVELOPED SEVERE CHOLANGITIS AFTER THE PROCEDURE REQUIRED INTENSIVE CARE AND DIED WITHIN 72 HOURS. PLEASE REFER TO THE REFERENCED ARTICLE FOR FULL DETAILS, DATA ANALYSIS, AND LIST OF PARTICIPATING INVESTIGATORS AND INSTITUTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280736 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death