BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 21421079 · Received February 20, 2025

    Report

    Report Number
    3005099803-2025-00532
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    December 19, 2024
    Report Date
    February 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729904595
    PMA / PMN Number
    DEN230019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE: PCU, QXH; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K)#: K150692, K153088, K181905, K220112, K233318; REPORTED HERE AS THE PREMARKET/510(K)# EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED TO CONTROL THE BLEEDING.

    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 DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO DEPLOY THE STENT; HOWEVER, THE DEVICE MISFIRED CAUSING THE STENT TO DISLODGE FROM THE IMPLANT SITE. THE STENT WAS RETRIEVED USING RAPTOR FORCEPS, AND A CLIP WAS USED TO CONTROL THE BLEEDING. ADDITIONALLY, DURING SCOPE PROCESSING, A PIECE OF THE DEVICE WAS DISCOVERED INSIDE THE SCOPE, WHICH WAS SUBSEQUENTLY REMOVED AND COLLECTED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465448 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553650 0034629913 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention