BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 20936439 · Received December 16, 2024

    Report

    Report Number
    3005099803-2024-05990
    Event Type
    Death
    Date Received
    December 16, 2024
    Date of Event
    January 1, 2019
    Report Date
    December 16, 2024
    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 THE PATIENTS' DEATHS WERE NOT REPORTED. THE RETROSPECTIVE STUDY START DATE OF JANUARY 1, 2019, IS USED FOR THE ESTIMATED DATE OF DEATH. BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY START DATE OF JANUARY 1, 2019, IS USED FOR THE ESTIMATED DATE OF EVENT. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: ALEXANDER JOHNSON PARKER; GREG TOKWABILULA; LAKSHMI NARSINGANALLORE VENKATESH; RANA BHATTACHARYA; JONATHAN BANNARD-SMITH; DANIEL HALEY; ABUBAKER Y M AHMED; ANTHONY WILSON; JOE GERAGHTY. "SEVERE ACUTE PANCREATITIS IN THE ERA OF ENDOSCOPICALLY PLACED LUMEN-APPOSING METAL STENTS (LAMS): CRITICAL CARE OUTCOMES FROM A LARGE UK PANCREATOBILIARY CENTRE." FRONTLINE GASTROENTEROLOGY 2024; 15:366-372. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE PATIENTS' DEATH.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE, SEVERE ACUTE PANCREATITIS IN THE ERA OF ENDOSCOPICALLY PLACED LUMEN-APPOSING METAL STENTS (LAMS): CRITICAL CARE OUTCOMES FROM A LARGE UK PANCREATOBILIARY CENTRE, BY ALEXANDER JOHNSON PARKER, ET AL. PER THE ARTICLE, A RETROSPECTIVE OBSERVATIONAL STUDY EXAMINED PATIENTS WITH SEVERE ACUTE PANCREATITIS (SAP) BETWEEN JANUARY 1, 2019, AND JUNE 16, 2022. AMONG PATIENTS TREATED WITH LAMS, 10% (3 PATIENTS) DIED DURING THEIR CRITICAL CARE STAY, AND 16% (5 PATIENTS) DIED BEFORE HOSPITAL DISCHARGE. 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
    2391495 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 Death