BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 21618954 · Received March 17, 2025

    Report

    Report Number
    3005099803-2025-00981
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    September 8, 2024
    Report Date
    March 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729904595
    PMA / PMN Number
    K233318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF EVENT WAS NOT REPORTED. THE ARTICLE PUBLISHED DATE IS USED FOR THE ESTIMATED DATE OF EVENT. THE SUSPECT DEVICE LOT NUMBER WAS NOT REPORTED. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. INITIAL REPORTER FACILITY NAME: INSTITUTION DO CANCER DO ESTADO DE SAO PAULO, DÉPARTEMENT DE ENDOSCOPIA; REPORTED HERE AS THE ADDRESS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. INITIAL REPORTER ADDRESS 1: AV. DR. ARNALDO, 251 - CERQUEIRA CESAR; REPORTED HERE AS THE ADDRESS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE: DIEGO CADENA AGUIRRE "BURIED LUMEN-APPOSING METAL STENT FOLLOWING EUS-GUIDED GASTROJEJUNOSTOMY: A RARE ADVERSE EVENT AND ITS MANAGEMENT" INSTITUTION DO CANCER DO ESTADO DE SAO PAULO, DEPARTAMENTO DE ENDOSCOPIA, SAO PAULO, BRAZIL,HTTPS://DOI.ORG/10.1016/J.VGIE.2024.08.015. IMDRF DEVICE CODE A22 CAPTURES THE REPORTABLE EVENT OF STENT OVERGROWTH. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF A NON-BSC DEVICE WAS USED TO COMPLETE THE PROCEDURE. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF A FOLLOW UP ESOPHAGOGASTRODUODENOSCOPY. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF CT-SCAN IMAGING WAS DONE.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF THE EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE "BURIED LUMEN-APPOSING METAL STENT FOLLOWING EUS-GUIDED GASTROJEJUNOSTOMY: A RARE ADVERSE EVENT AND ITS MANAGEMENT" BY DIEGO CADENA AGUIRRE, ET AL. PER THE ARTICLE, A 78-YEAR-OLD MALE UNDERWENT A RIGHT HEMICOLECTOMY WITH ILEOTRANSVERSE ANASTOMOSIS DUE TO RIGHT-SIDED COLON ADENOCARCINOMA. IN THE FIFTH YEAR OF FOLLOW-UP, HE DEVELOPED CHOLESTATIC SYNDROME SECONDARY TO A LARGE DUODENAL METASTATIC MASS. ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY WAS PERFORMED USING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. AFTER THREE WEEKS, A SCHEDULED FOLLOW-UP ESOPHAGOGASTRODUODENOSCOPY REVEALED THAT THE LUMEN APPOSING METAL STENT WAS PARTIALLY COVERED WITH GASTRIC MUCOSA. TO PREVENT COMPLETE OBSTRUCTION, AN ESOPHAGEAL STENT WAS PLACED INSIDE THE LAMS. LEASE SEE THE REFERENCE ARTICLE FOR FULL DETAILS. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS IMPLANTED TO TREAT A MALIGNANT 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 >= 6 CM IN SIZE AND WALLED-OFF NECROSIS >= 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565562 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553650 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention