BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 22771044 · Received August 11, 2025

    Report

    Report Number
    3005099803-2025-03921
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    January 1, 2020
    Report Date
    August 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729904564
    PMA / PMN Number
    K150692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE OF JANUARY 1, 2020, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN JANUARY 1, 2020, AND JANUARY 31, 2024. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WERE 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 G2: LITERATURE SOURCE: GIUSEPPE VANELLA; FRANCESCO FRIGO; ROBERTO LEONE; MATEO TACELLI; NICOLE LISCIA; LUIGI LETA; NICOLO PECORELLI; GIULIO BELFIORI, MICHELE RENE; MASSIMO FALCONI; GABRIELE CAPURSO; PAOLO G. ARCIDIACONO. "OUTCOMES OF EUS-GUIDED GALLBLADDER DRAINAGE IN ACUTE CHOLECYSTITIS WITH CONTAINED PERFORATION: A PROSPECTIVE COHORT" EUROPEAN SOCIETY OF GASTROINTESTINAL ENDOSCOPY, HTTPS://DOI.ORG/10.1016/J.GIE.2025.03.934. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE TITLED "OUTCOMES OF EUS-GUIDED GALLBLADDER DRAINAGE IN ACUTE CHOLECYSTITIS WITH CONTAINED PERFORATION: A PROSPECTIVE COHORT", BY GIUSEPPE VANELLA ET AL. PER THE ARTICLE, BETWEEN 2020 AND 2024, 48 PATIENTS SUFFERING FROM ACUTE CHOLECYSTITIS AND CONTAINED PERFORATION UNDERWENT EUS-GUIDED GALLBLADDER DRAINAGE (EUS-GBD) USING AXIOS AS LUMEN-APPOSING METAL STENTS (LAMS). TWO PATIENTS EXPERIENCED STENT MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035158 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553540 08714729904564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown