BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX BILIARY

    MDR report key: 22906929 · Received August 27, 2025

    Report

    Report Number
    3005099803-2025-04371
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    June 1, 2018
    Report Date
    August 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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: BANG JY, NAVANEETHAN U, HASAN MK, SUTTON B, HAWES R, VARADARAJULU S. NON-SUPERIORITY OF LUMEN-APPOSING METAL STENTS OVER PLASTIC STENTS FOR DRAINAGE OF WALLED-OFF NECROSIS IN A RANDOMISED TRIAL. GUT. 2019 JUL;68(7):1200-1209. DOI: 10.1136/GUTJNL-2017-315335. EPUB 2018 JUN 1. PMID: 29858393; PMCID: PMC6582745. BLOCK H6: IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF OBSTRUCTION WITHIN DEVICE.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE "NON-SUPERIORITY OF LUMEN-APPOSING METAL STENTS OVER PLASTIC STENTS FOR DRAINAGE OF WALLED-OFF NECROSIS IN A RANDOMISED TRIAL", BY JI YOUNG BANG, ET AL. PER THE ARTICLE, BETWEEN FEBRUARY 2016 AND MARCH 2017, 80 PATIENTS WERE SCREENED AS PART OF A RANDOMIZED CLINICAL TRIAL WAS CONDUCTED TO COMPARE THE EFFICACY AND SAFETY OF LUMEN-APPOSING METAL STENTS (LAMS), VERSUS PLASTIC STENTS FOR ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS (WON). A TOTAL OF 60 PATIENTS WERE ENROLLED, WITH 29 RECEIVING PLASTIC STENTS. NO SIGNIFICANT DIFFERENCES WERE OBSERVED BETWEEN LUMEN-APPOSING METAL STENTS (LAMS) AND PLASTIC STENTS REGARDING TECHNICAL AND CLINICAL SUCCESS, NUMBER OF PROCEDURES, HOSPITAL READMISSIONS, OR OVERALL TREATMENT OUTCOMES. THE ONLY NOTABLE DISTINCTION WAS A SHORTER PROCEDURE DURATION WITH LAMS. IN THE PLASTIC STENT GROUP, ADVERSE EVENTS WERE LIMITED BUT INCLUDED MIGRATION OF THE STENTS INTO THE JEJUNUM IN TWO PATIENTS. THESE MIGRATED STENTS WERE SUCCESSFULLY RETRIEVED ENDOSCOPICALLY USING RAT-TOOTH FORCEPS. ADDITIONALLY, PARTIAL PANCREATIC DUCT DISRUPTION WAS IDENTIFIED AND MANAGED WITH TRANSPAPILLARY STENT PLACEMENT TO BRIDGE THE LEAK AND ENSURE RESOLUTION. PLEASE REFER TO THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251473 ADVANIX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention