BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23980269 · Received January 6, 2026

    Report

    Report Number
    3005099803-2026-00052
    Event Type
    Injury
    Date Received
    January 6, 2026
    Date of Event
    January 1, 2017
    Report Date
    January 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K220112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE STUDY WAS CONDUCTED. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. 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: MANUEL PEREZ-MIRANDA, ET. AL., ": LONG- TERM CLINICAL SUCCESS OF ENDOSCOPIC ULTRASOUND- GUIDED GASTROENTEROSTOMY IN BENIGN GASTRIC OUTLET OBSTRUCTION" DIGESTIVE ENDOSCOPY, 2025; 37:1198-1206. HTTPS://DOI.ORG/10.1111/DEN.15087. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE DEVICE EVENT OF STENT MIGRATION. IMDRF PATIENT CODE E2114 CAPTURES THE PATIENT COMPLICATION OF PERFORATION. IMDRF IMPACT CODE F08 CAPTURES THE ASSOCIATED PATIENT HOSPITALIZATION RESULTING FROM THESE COMPLICATIONS. IMDRF IMPACT CODE F2302 CAPTURES THE MEDICATION ADMINISTERED TO MANAGE THE PATIENT'S COMPLICATIONS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH AN ARTICLE TITLED, "LONG- TERM CLINICAL SUCCESS OF ENDOSCOPIC ULTRASOUND- GUIDED GASTROENTEROSTOMY IN BENIGN GASTRIC OUTLET OBSTRUCTION", BY MANUEL PEREZ- MIRANDA, ET AL. THE STUDY AIMED TO EVALUATE LONG-TERM CLINICAL OUTCOMES OF EUS-GE IN BENIGN GASTRIC OUTLET OBSTRUCTION (BGOO). ACCORDING TO THE ARTICLE, A MULTICENTER RETROSPECTIVE STUDY WAS CONDUCTED ACROSS NINE CENTERS INVOLVING PATIENTS WHO UNDERWENT EUS-GE FOR THE TREATMENT OF BGOO. PATIENTS SCHEDULED FOR EUS-GE WITH LAMS BETWEEN JANUARY 2017 AND JUNE 2023 WERE CONSIDERED ELIGIBLE. THERE WERE 62 PATIENTS INCLUDED FOR ANALYSIS. MOST CASED OF BGOO WERE RELATED TO PANCREATIC DISEASE. ONE OF THE STUDY PATIENTS, A 65-YEAR-OLD MALE WITH SEVERE POST-ERCP AP, WHO PRESENTED 28 DAYS POST LAMS DEPLOYMENT WITH ABDOMINAL PAIN, FEVER, AND VOMITING. CT IMAGING REVEALED LAMS CONTACT WITH THE TRANSVERSED COLON, WITH COLONIC WALL THICKENING, MINIMAL AIR BUBBLES AND GRADE I ASCITES. THE PATIENT WAS MANAGED WITH INTRAVENOUS ANTIBIOTICS, REQUIRING A ONE-MONTH HOSPITALIZATION. THE LAMS WAS UNEVENTFULLY REMOVED 6 MONTHS LATER NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION. HOWEVER, THE AXIOS STENT ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE STATE THAT "THE AXIOS STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF: A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH GREATER THAN OR EQUAL TO 70% FLUID CONTENT; THE GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK FOR, OR UNSUITABLE FOR, SURGERY; AND THE BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE." THE STENT IS NOT INTENDED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33403 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| H