BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 21422528 · Received February 20, 2025

    Report

    Report Number
    3005099803-2025-00535
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    January 28, 2025
    Report Date
    March 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    00191506008093
    PMA / PMN Number
    K203132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE): PCU; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K233318; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION PERFORMED TO REMOVE THE STENT AND CLOSE THE PUNCTURE SITE.

    Additional Manufacturer Narrative · 0

    BLOCK H6 (PATIENT CODES) HAS BEEN CORRECTED. BLOCK D2B: PRO CODE (PRODUCT CODE): PCU; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K233318; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION PERFORMED TO REMOVE THE STENT AND CLOSE THE PUNCTURE SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TO TREAT CHOLECYSTITIS DURING A ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS SLOW TO EXPAND, BUT THE PHYSICIAN WAS ABLE TO OPEN IT BY MANIPULATING THE CATHETER. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL STENT. ONE DAY AFTER STENT PLACEMENT, THE PATIENT EXPERIENCED PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THERE IS AIR AND THAT THE STENT HAD MIGRATED, WITH THE DISTAL FLANGE LOCATED IN THE STOMACH AND THE PROXIMAL FLANGE IN THE PERITONEUM. THE STENT WAS SUCCESSFULLY REMOVED, AND TWO CLIPS WERE PLACED TO CLOSE THE PUNCTURE SITE. THE PATIENT'S CONDITION IMPROVED FOLLOWING THE REMOVAL OF THE STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TO TREAT CHOLECYSTITIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT WAS SLOW TO EXPAND, BUT THE PHYSICIAN WAS ABLE TO OPEN IT BY MANIPULATING THE CATHETER. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL STENT. ONE DAY AFTER STENT PLACEMENT, THE PATIENT EXPERIENCED PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THERE IS AIR AND THAT THE STENT HAD MIGRATED, WITH THE DISTAL FLANGE LOCATED IN THE STOMACH AND THE PROXIMAL FLANGE IN THE PERITONEUM. THE STENT WAS SUCCESSFULLY REMOVED, AND TWO CLIPS WERE PLACED TO CLOSE THE PUNCTURE SITE. THE PATIENT'S CONDITION IMPROVED FOLLOWING THE REMOVAL OF THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411968 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553690 0035388737 00191506008093

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention