BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23392092 · Received October 27, 2025

    Report

    Report Number
    3005099803-2025-05556
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    September 16, 2022
    Report Date
    October 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729951100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE OF SEPTEMBER 16, 2022, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN SEPTEMBER 16, 2022, AND NOVEMBER 24, 2024. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WERE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE: SHYAM VARADARAJULU; JI YOUNG BANG; RAJESH PURI; SUNDEEP LAKHTAKIA; SHYAM THAKKAR; IRVING WAXMAN; IMRAN SIDDIQUI; KRISTEN ARNOLD, ADARSH CHAUDHARY; SHUBHAM MEHTA; AMANJEET SINGH; GUDURU VENKAT RAO; JAHANGEER BASHA; RAJESH GUPTA; SHREEYASH MODAK; SHAILENDRA SINGH; BRIAN BOONE; PHILIP DAUTEL; MATTHEW E B DIXON; HYUNGJIN MYRA KIM; BRYCE SUTTON; JUAN PABLO ARNOLETTI; THOMAS ROSCH. "ENDOSCOPIC OR SURGICAL GASTROENTEROSTOMY FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION: A RANDOMIZED TRIAL" GUT BMJ GROUP ENDOSCOPY, HTTPS://DOI:10.1136/GUTJNL-2025-336339. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF A PERFORATION. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF THE ADDITIONAL DEVICE REQUIRED TO CLOSE THE WOUND (OVER-THE-SCOPE CLIPS).

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING AXIOS STENTS AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS THROUGH THE ARTICLE "ENDOSCOPIC OR SURGICAL GASTROENTEROSTOMY FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION: A RANDOMIZED TRIAL" BY VARADARAJUL ET AL. PER ARTICLE, BETWEEN SEPTEMBER 16, 2022, AND NOVEMBER 24, 2024, A TOTAL OF 116 PATIENTS SUFFERING FROM GASTRIC OUTLET OBSTRUCTION WERE TREATED WITH TWO TECHNIQUES: SGJ AND EUS-GE USING LUMEN APPOSING METAL STENTS. DURING ONE PROCEDURE, IT WAS REPORTED THAT A PATIENT EXPERIENCED GASTRIC PERFORATION DURING DEPLOYMENT OF A LUMEN APPOSING METAL STENT. THE STENT WAS REMOVED, AND THE PERFORATION WAS SUCCESSFULLY CLOSED USING TWO OVER-THE-SCOPE CLIPS. THE EUS-GE WAS THEN COMPLETED DURING THE SAME SESSION. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS IMPLANTED TO TREAT A GASTRIC OUTLET OBSTRUCTION. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS MORE THAN OR EQUAL TO 6 CM IN SIZE AND WALLED-OFF NECROSIS OF MORE THAN OR EQUAL TO 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO BE PLACED FOR THE TREATMENT OF GASTRIC OUTLET OBSTRUCTION. PLEASE SEE THE REFERENCE ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2735029 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553560 08714729951100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention