BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 22906285 · Received August 27, 2025

    Report

    Report Number
    3005099803-2025-04353
    Event Type
    Death
    Date Received
    August 27, 2025
    Date of Event
    January 1, 2023
    Report Date
    August 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K233318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. LITERATURE SOURCE: KARSTENSEN, J. G.; NOVOVIC, S.; HANSEN, E. F.; JENSEN, A. B.; JOERGENSEN, H. L.; LAURITSEN, M. L.; WERGE, M. P.; SCHMIDT, P. N. "EUS-GUIDED DRAINAGE OF LARGE WALLED-OFF PANCREATIC NECROSES USING PLASTIC VERSUS LUMEN-APPOSING METAL STENTS: A SINGLE-CENTRE RANDOMISED CONTROLLED TRIAL." GUT, 72(6), 1167-1173. ARTICLE 328225. HTTPS://DOI.ORG/10.1136/GUTJNL-2022-328225. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE: "EUS-GUIDED DRAINAGE OF LARGE WALLED-OFF PANCREATIC NECROSES USING PLASTIC VERSUS LUMEN-APPOSING METAL STENTS: A SINGLE-CENTRE RANDOMISED CONTROLLED TRIAL," BY JOHN GASDAL KARSTENSEN, ET AL. PER THE ARTICLE, A SINGLE-CENTRE, OPEN-LABEL, RANDOMIZED CONTROLLED SUPERIORITY TRIAL WAS CONDUCTED USING AN ENDOSCOPIC STEP-UP APPROACH IN PATIENTS WITH PANCREATIC WALLED-OFF NECROSIS (WON) LARGER THAN 15 CM. THE STUDY INCLUDED 22 PATIENTS TREATED WITH THE TRADITIONAL DOUBLE PIGTAIL TECHNIQUE (DPT) AND 20 PATIENTS TREATED WITH LUMEN-APPOSING METAL STENTS (LAMS). THE OVERALL MORTALITY RATE AMONG PARTICIPANTS WAS 4.8%. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS AND FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405790 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L