BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 19810823 · Received July 23, 2024

    Report

    Report Number
    3005099803-2024-03547
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    January 1, 2017
    Report Date
    July 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT EVENT DATE IS UNKNOWN; EVENT OCCURRED BETWEEN JANUARY 2017 AND JANUARY 2022. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK G2: LITERATURE SOURCE: PAOLO G.A. ET AL. CLASSIFICATION, RISK FACTORS, AND MANAGEMENT OF LUMEN APPOSING METAL STENT DYSFUNCTION DURING FOLLOW-UP OF ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY: MULTICENTER EVALUATION FROM THE LEUVEN-AMSTERDAM-MILAN STUDY GROUP. DIGESTIVE ENDOSCOPY 2023; 35: 377-388. BLOCK H6: IMDRF PATIENT CODE E1108 CAPTURES THE REPORTABLE EVENT OF BILIARY LEAK. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION. IMDRF DEVICE CODE A22 CAPTURES THE REPORTABLE EVENT OF STENT OVERGROWTH. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY FOR CHOLEDOCHODUODENOSTOMY PROCEDURE. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC PROCEDURE PERFORMED. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION PERFORMED.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE "CLASSIFICATION, RISK FACTORS, AND MANAGEMENT OF LUMEN APPOSING METAL STENT DYSFUNCTION DURING FOLLOW-UP OF ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY: MULTICENTER EVALUATION FROM THE LEUVEN-AMSTERDAM-MILAN STUDY GROUP" BY PAOLO GIORGIO ARCIDIACONO, ET AL. PER THE ARTICLE, BETWEEN JANUARY 2017 AND JANUARY 2022 THE FOLLOWING OCCURRED WITH STUDY PATIENTS: STENT DYSFUNCTIONS, INCLUDING MISDEPLOYMENT, OCCLUSION, OVERGROWTH, AND MIGRATION. ADDITIONALLY, SOME PATIENTS EXPERIENCED BILIARY LEAKS, CHOLANGITIS, CHOLECYSTITIS, ASCITES AND PERFORATION. THE STENT DYSFUNCTIONS AND PATIENT COMPLICATIONS REPORTED WERE MANAGED THROUGH THE PLACEMENT OF COAXIAL DOUBLE PIGTAIL PLASTIC STENTS (DPPS), BALLOON/BASKET SWIPES, METAL STENT INSERTIONS, ANTIBIOTICS, ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY (EUS-CDS), ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS), PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD), ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE (EUS-GBD) AND SURGICAL BILIODIGESTIVE ANASTOMOSIS. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472240 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention