BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 21329036 · Received February 6, 2025

    Report

    Report Number
    3005099803-2025-00288
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729904595
    PMA / PMN Number
    K233318
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL PRO CODES: PCU, QXH. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PANCREATIC CYST DURING A PANCREATIC CYST GASTRIC BYPASS PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS DEPLOYED AS CONFIRMED BY ECHO AND FLUOROSCOPY; HOWEVER, WHEN THE SCOPE WAS REMOVED, IT WAS NOTED THAT THE STENT DISLODGED INTO THE STOMACH. SUBSEQUENTLY, THE STENT WAS REMOVED WITH GRASPING FORCEPS AND AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) CATHETER WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247369 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553650 0034730946 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention