BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 21878042 · Received April 21, 2025

    Report

    Report Number
    3005099803-2025-01783
    Event Type
    Death
    Date Received
    April 21, 2025
    Date of Event
    January 1, 2015
    Report Date
    April 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B2: THE EXACT DATE OF DEATH WAS NOT REPORTED. IT WAS ESTIMATED TO BE JANUARY 31, 2015, BASED ON 30 DAYS FROM THE ESTIMATED EVENT DATE OF JANUARY 1, 2025. BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE ESTIMATED EVENT DATE OF JANUARY 1, 2015, IS USED, BASED ON THE START OF THE RETROSPECTIVE STUDY IN JANUARY 2015. 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 G2: LITERATURE SOURCE: JAMES GAUCI; WEI ON; BHARAT PARANANDI; MATTHEW THOMAS HUGGETT; SIMON EVERETT. "COMBINED ENDOSCOPIC ULTRASONOGRAPHY AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION IS ASSOCIATED WITH REDUCED TIME TO ONCOLOGICAL THERAPY COMPARED WITH ERCP AND SAMPLING ALONE." PANCREAS 2025; 54:E101-E106. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF HEMORRHAGE. IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PANCREATITIS. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PERFORATION. IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF SEPSIS. IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF CARDIOPULMONARY EVENTS. IMDRF IMPACT CODE F02 CAPTURES THE REPORTED FATALITIES. IMDRF IMPACT CODE F12 CAPTURES THE SERIOUS INJURY RESULTING FROM REPORTED PATIENT HARMS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE: "COMBINED ENDOSCOPIC ULTRASONOGRAPHY AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION IS ASSOCIATED WITH REDUCED TIME TO ONCOLOGICAL THERAPY COMPARED WITH ERCP AND SAMPLING ALONE," BY JAMES GAUCI, ET AL. PER THE ARTICLE, A RETROSPECTIVE STUDY EXAMINED PATIENTS WHO UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE BETWEEN JANUARY 2015 AND DECEMBER 2020. AMONG PATIENTS, THE FOLLOWING OUTCOMES WERE REPORTED: HEMORRHAGE, PANCREATITIS, PERFORATION, SEPSIS, CARDIOPULMONARY EVENTS AND DEATH. 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
    1261149 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 Other| D| R