BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS

    MDR report key: 20819713 · Received December 2, 2024

    Report

    Report Number
    3005099803-2024-06125
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    00191506008086
    PMA / PMN Number
    K203132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE : KNS, PCU; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K) # : K203132, K233318; REPORTED HERE AS THE PREMARKET / 510(K) # EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150207 CAPTURES THE REPORTABLE EVENT OF DELIVERY SYSTEM DIFFICULT TO REMOVE.

    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 TRANSDUODENAL TO THE COMMON BILE DUCT FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY, BUT IT TOOK A WHILE TO EXPAND, MAKING REMOVAL OF THE DELIVERY SYSTEM DIFFICULT. THE PHYSICIAN WAITED FOR APPROXIMATELY 30 SECONDS BEFORE THE STENT EVENTUALLY EXPANDED AND THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED FOR BILIARY DRAINAGE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE, THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL AND ARE FREE OF SOLID DEBRIS. THE DEVICE IS NOT INDICATED TO BE PLACED IN THE COMMON BILE DUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133043 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553680 0034277692 00191506008086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown