BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 20334540 · Received September 30, 2024

    Report

    Report Number
    3005099803-2024-04830
    Event Type
    Death
    Date Received
    September 30, 2024
    Date of Event
    September 1, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK E1: THE HEALTHCARE FACILITY NAME IS (B)(6) MEDICAL CENTER. (B)(6) UNITED STATES. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS IMPLANTED IN THE PYLORUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST STENT PLACEMENT, ON AN UNKNOWN DATE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLICATIONS. REPORTEDLY, THE PATIENT DID NOT RETURN FOR A FOLLOW-UP, AND THE AXIOS STENT BECAME EMBEDDED IN THE MUCOSA. SUBSEQUENTLY, THE STENT WAS REMOVED CAUSING BLEEDING THAT RESULTED IN THE PATIENT'S DEATH. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS IMPLANTED IN THE PYLORUS. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE AND WALLED-OFF NECROSIS >= 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO BE PLACED IN THE PYLORUS. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038609 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| D