BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 21859797 · Received April 17, 2025

    Report

    Report Number
    3005099803-2025-01669
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    July 1, 2018
    Report Date
    April 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF JULY 1, 2018, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE START OF THE RETROSPECTIVE STUDY DATE OF JULY 2018. BLOCK D4, H4: DETAILED PRODUCT INFORMATION, INCLUDING DEVICE AVAILABILITY FOR EVALUATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. 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 E1 (INITIAL REPORTER ADDRESS 1): THE INITIAL REPORTER ADDRESS IS 4 PLACE DU PROFESSEUR ROBERT-DEBRE. BLOCK G2: LITERATURE SOURCE: ANTOINE DEBOURDEAU; JULES DANIEL; LUDOVIC CAILLO; ERIC ASSENAT; PHILIPPE POUDEROUX; JEAN-FRANCOIS BOURGAUX; MARTIN BERTRAND; THOMAS BARDOL. "EFFECTIVENESS OF ENDOSCOPIC ULTRASOUND (EUS)-GUIDED CHOLEDOCHODUODENOSTOMY VS. EUS-GUIDED GALLBLADDER DRAINAGE FOR JAUNDICE IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION AFTER FAILED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: RETROSPECTIVE, MULTICENTER STUDY (GALLBLADEUS STUDY)." DIGESTIVE ENDOSCOPY 2025; 37: 103-114. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT DISLODGEMENT. IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BLEEDING. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PERFORATION. IMDRF PATIENT CODE E1901 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BACTEREMIA. IMDRF PATIENT CODE E1024 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF BILIARY PERITONITIS. IMDRF IMPACT CODE F1901 CAPTURES THE POST-DRAINAGE SURGERY AND BILIARY PERITONITIS NECESSITATING SURGICAL TREATMENT. IMDRF IMPACT CODE F0801 CAPTURES THE INTENSIVE CARE UNIT (ICU) ADMISSION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE: "EFFECTIVENESS OF ENDOSCOPIC ULTRASOUND (EUS)-GUIDED CHOLEDOCHODUODENOSTOMY VS. EUS-GUIDED GALLBLADDER DRAINAGE FOR JAUNDICE IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION AFTER FAILED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: RETROSPECTIVE, MULTICENTER STUDY (GALLBLADEUS STUDY)," BY ANTOINE DEBOURDEAU, ET AL. PER THE ARTICLE, A MULTICENTER RETROSPECTIVE STUDY INCLUDED 78 PATIENTS WITH OBSTRUCTIVE JAUNDICE SECONDARY TO MALIGNANT DISTAL BILIARY OBSTRUCTION (MDBO) WHO UNDERWENT ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE (EUS-GBD) (41 PATIENTS) OR ENDOSCOPIC ULTRASOUND-GUIDED CHOLEDOCHODUODENOSTOMY (EUS-CDS) (37 PATIENTS) WITH LUMEN-APPOSING METAL STENTS AFTER FAILED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) BETWEEN JULY 2018 AND JULY 2022. THE FOLLOWING OUTCOMES WERE REPORTED: STENT DISLODGEMENT, STENT OBSTRUCTION, BLEEDING, PERFORATION, BACTEREMIA, POST-DRAINAGE SURGERY, BILIARY PERITONITIS NECESSITATING SURGICAL TREATMENT, AND INTENSIVE CARE UNIT (ICU) ADMISSION. 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
    20016 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION UNK-P-HOT_AXIOS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O