BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 11787027 · Received May 6, 2021

    Report

    Report Number
    3005099803-2021-02070
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 6, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2021 AS NO SPECIFIC EVENT DATE WAS REPORTED. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 16, 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TRANSGASTRIC TO THE JEJUNUM DURING A GASTROJEJUNOSTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH AND ANOTHER AXIOS STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. NOTE: ACCORDING TO THE COMPLAINANT, THE AXIOS STENT WAS PLACED FOR A GASTROJEJUNOSTOMY. HOWEVER, PER THE HOT 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 FOR PLACEMENT TRANSGASTRIC TO THE JEJUNUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682321 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553550 0026580997

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention