BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 15623971 · Received October 18, 2022

    Report

    Report Number
    3005099803-2022-06110
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 26, 2022
    Report Date
    October 18, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 28, 2022, THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE STOMACH TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO) DURING A GASTRO-ENTERAL ANASTOMOSIS PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE AXIOS CAUTERY DID NOT WORK. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED IN THE STOMACH TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO). HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH >= 70% FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED TO TREAT GASTRIC OUTLET OBSTRUCTION (GOO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390609 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553550 0029576263

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown