BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 16124801 · Received January 9, 2023

    Report

    Report Number
    3005099803-2022-07839
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    January 1, 2015
    Report Date
    January 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED BETWEEN (B)(6) 2015 TO (B)(6) 2020. LITERATURE SOURCE: RUBEN S-A., JOSE CARLOS I., BELEN MARTINEZ M., JOAN G., ET AL. EIJS-GUIDED GASTROENTEROSTOMY VERSUS DUODENAL SELF-EXPANDABLE METAL STENT FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION: RESULTS FROM A NATIONWIDE MULTICENTER RETROSPECTIVE STUDY. GASTROINTESTINAL ENDOSCOPY; 2022; 96:1012-20. INITIAL REPORTER ADDRESS 1: (B)(6) (B)(4).

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT FROM REFERENCED LITERATURE ARTICLE "EUS-GUIDED GASTROENTEROSTOMY VERSUS DUODENAL SELF-EXPANDABLE METAL STENT FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION: RESULTS FROM A NATIONWIDE MULTICENTER RETROSPECTIVE STUDY." ACCORDING TO THE LITERATURE, AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TO TREAT A GASTRIC OUTLET OBSTRUCTION DURING AN ENDOSCOPIC ULTRASOUND-GUIDED GASTROENTEROSTOMY (EUS-GE) PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT STENT MIS DEPLOYMENT WAS ENCOUNTERED. THE PATIENT ALSO EXPERIENCED BLEEDING. ONE BLEEDING WAS NOTED AT THE ANASTOMOSIS WHICH WAS TREATED WITH ENDOSCOPY PROCEDURE. THE SECOND BLEEDING WAS ALSO NOTED AT THE ANASTOMOSIS AND A SURGERY WAS PERFORMED AFTER FAILED ATTEMPT OF ENDOSCOPY AND RADIOLOGY THERAPY. PERFORATION WAS ALSO EXPERIENCED BY THE PATIENT, WHICH WAS GIVEN WITH PALLIATIVE TREATMENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT A GASTRIC OUTLET OBSTRUCTION. 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 HOT AXIOS IS NOT INDICATED TO BE IMPLANTED IN A GASTRIC OUTLET OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563963 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention