BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 19162686 · Received April 23, 2024

    Report

    Report Number
    3005099803-2024-01743
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 26, 2024
    Report Date
    June 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DELIVERY SYSTEM DIFFICULT TO ADVANCE FOR GASTROJEJUNOSTOMY PROCEDURE. H11: BLOCKS E1 (INITIAL REPORTER TITLE, INITIAL REPORTER FIRST NAME, INITIAL REPORTER LAST NAME, INITIAL REPORTER FACILITY NAME, INITIAL REPORTER ADDRESS 1, INITIAL REPORTER CITY, INITIAL REPORTER COUNTRY, INITIAL REPORTER ZIP/POST CODE AND INITIAL REPORTER PHONE), E2, E3 AND H11 HAVE BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON MAY 8, 2024.

    Additional Manufacturer Narrative · 0

    BLOCK E1: THE REPORTED HEALTHCARE FACILITY IS: (B)(6). BLOCK H6: IMDRF DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DELIVERY SYSTEM DIFFICULT TO ADVANCE FOR GASTROJEJUNOSTOMY PROCEDURE.

    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 TRANSGASTRIC TO THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION DURING A GASTROJEJUNOSTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A PUNCTURE WAS CREATED, BUT THERE WAS RESISTANCE WHEN THE AXIOS DELIVERY SYSTEM WAS ADVANCED THROUGH THE SCOPE AND DURING THE ATTEMPTED DEPLOYMENT. THE STENT WAS ABLE TO BE FULLY DEPLOYED, BUT THE PHYSICIAN FELT "UNSAFE" AS IT FELT LIKE IT JUMPED WHEN PULLED BACK. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE DEVICE WAS INTENDED TO BE PLACED DURING A GASTROJEJUNOSTOMY DRAINAGE PROCEDURE. THE IFU STATES, "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 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 AXIOS STENT IS NOT INDICATED TO BE PLACED TRANSGASTRIC TO THE JEJUNUM.

    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 TRANSGASTRIC TO THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION DURING A GASTROJEJUNOSTOMY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A PUNCTURE WAS CREATED, BUT THERE WAS RESISTANCE WHEN THE AXIOS DELIVERY SYSTEM WAS ADVANCED THROUGH THE SCOPE AND DURING THE ATTEMPTED DEPLOYMENT. THE STENT WAS ABLE TO BE FULLY DEPLOYED, BUT THE PHYSICIAN FELT "UNSAFE" AS IT FELT LIKE IT JUMPED WHEN PULLED BACK. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE DEVICE WAS INTENDED TO BE PLACED DURING A GASTROJEJUNOSTOMY DRAINAGE PROCEDURE. THE IFU STATES, "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 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 AXIOS STENT IS NOT INDICATED TO BE PLACED TRANSGASTRIC TO THE JEJUNUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328499 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553550 0033095157

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown