BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23561583 · Received November 14, 2025

    Report

    Report Number
    3005099803-2025-06114
    Event Type
    Death
    Date Received
    November 14, 2025
    Date of Event
    September 1, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K233318
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE UPN AND/OR LOT NUMBER. 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 H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE EVENT OF ABSCESS. IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF PATIENT CODE E0505 CAPTURES THE REPORTABLE EVENT OF HEMATOMA. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF INFECTION. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TO TREAT A BILIARY SEPSIS DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANS GASTRIC ERCP (EDGE) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, AN IMPLANTED WAS ATTEMPT WITH THE FIRST DEVICE, WHERE THE DISTAL FLANGE FAILED TO DEPLOY DESPITE A SUCCESSFUL CAUTERY-ASSISTED PUNCTURE. A GUIDEWIRE WAS INTRODUCED, THOUGH IT COULD NOT PASS THROUGH THE DISTAL END OF THE DELIVERY SYSTEM. AS A RESULT, IT WAS REMOVED. THEREFORE, A SECOND STENT WAS THEN SUCCESSFULLY PLACED ADJACENT TO THE INITIAL PUNCTURE SITE (SUBJECT OF THIS DEVICE). ERCP WAS NOT PERFORMED DURING THIS PROCEDURE. HOWEVER, FOLLOWING DEPLOYMENT OF THE SECOND AXIOS, THERE WAS EVIDENCE OF BLOOD BETWEEN THE GASTRIC POUCH AND THE EXCLUDED STOMACH, WHICH APPEARED ENDOSONOGRAPHICALLY AS HYPERECHOIC FLUID. POST PROCEDURE, THE PATIENT HAD EVIDENCE OF ONGOING BLEEDING AND ULTIMATELY REQUIRED IR EMBOLIZATION FOR CONTROL OF BLEEDING. SUBSEQUENTLY, THE PATIENT DEVELOPED WORSENING SEPSIS OF UNCLEAR ORIGIN, BILIARY SEPSIS OR AN INFECTED HEMATOMA WERE CONSIDERED. AS THE CLINICAL CONDITION DETERIORATED, CARE WAS WITHDRAWN. IT WAS REPORTED THAT THE PATIENT PASSED AWAY APPROXIMATELY 48 HOURS AFTER THE PROCEDURE; HOWEVER, THE CAUSE OF DEATH REMAINS UNKNOWN AT THIS TIME. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT PYLORIC STENOSIS DURING AN EDGE PROCEDURE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANS GASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM OR LARGER IN SIZE AND WALLED-OFF NECROSIS 6 CM OR LARGER IN SIZE WITH AT LEAST 70% FLUID CONTENT, PROVIDED THEY ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO TREAT PYLORIC STENOSIS DURING AN EDGE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715269 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death