BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 25174323 · Received May 14, 2026

    Report

    Report Number
    3005099803-2026-01893
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729904571
    PMA / PMN Number
    K220112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF IMPACT CODE F08 CAPTURES THE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION. IMDRF IMPACT CODE F1906 CAPTURES THE EVENT OF MODIFIED SURGICAL PROCEDURE. IMDRF IMPACT CODE F0801 CAPTURES THE EVENT OF INTENSIVE CARE. IMDRF IMPACT CODE F2303 CAPTURES THE EVENT OF MEDICATION REQUIRED.

    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 TRANSGASTRIC TO PANCREAS TO TREAT A SYMPTOMATIC PANCREATIC WALLED-OFF NECROSIS (WON) DURING A ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE FIRST FLANGE WAS ABLE TO OPEN WITHIN THE WALLED-OFF NECROSIS CAVITY AS NORMAL USING STANDARD EUS TECHNIQUE. HOWEVER, THE PHYSICIAN REPORTED THAT THE SECOND FLANGE OF THE STENT DID NOT OPEN IN THE GASTRIC LUMEN REMAINING NARROW/COMPRESSED, AND IT EVENTUALLY MIGRATED INTO THE WALLED-OFF NECROSIS CAVITY BEFORE IT COULD BE REPOSITIONED. THE PHYSICIAN THEN SWITCHED TO A GASTROSCOPE, AND THE PUNCTURE SITE WAS VISIBLE, BUT NO STENT COMPONENT WAS VISIBLE TO RETRIEVE OR REPOSITION. THE PROCEDURE WAS COMPLETED WITH A NASOJEJUNAL TUBE (NJT) PLACED FOR FEEDING AND NIL BY MOUTH (NBM). THE DEVICE REMAINS IMPLANTED. THE PATIENT EXPERIENCED SEVERE PAIN AND WAS KEPT HOSPITALIZED FOR CRITICAL CARE FOR ANALGESIA, INTRAVENOUS ANTIBIOTICS, AND OBSERVATION WITH THE PUNCTURE SITE REMAINING OPEN. HOWEVER, IT HAS ALSO BEEN REPORTED THAT THE PATIENT IS CURRENTLY STABLE AND HAS BEEN STEPPED DOWN FROM CRITICAL CARE. THE STENT REMAINS IN SITU, AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85065 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553550 0038695624 08714729904571

    Patients

    Seq Age Sex Outcome Treatment
    1