BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 21154190 · Received January 14, 2025

    Report

    Report Number
    3005099803-2024-06920
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    December 29, 2022
    Report Date
    January 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K220112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS NO. 21, SECTION 2, NANYA S. ROAD; REPORTED HERE AS THE ADDRESS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. LITERATURE SOURCE: CHEN-SHUAN CHUNG ET AL. RESCUING MALDEPLOYMENT OF LUMEN-APPOSING METAL STENT FOR THE MANAGEMENT OF ACUTE CHOLECYSTITIS. DIGESTIVE ENDOSCOPY (2023) 35:670. DOI: 10.1111/DEN.14572. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE DIFFICULT TO POSITION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT FROM REFERENCED LITERATURE ARTICLE "RESCUING MALDEVELOPMENT OF LUMEN-APPOSING METAL STENT FOR THE MANAGEMENT OF ACUTE CHOLECYSTITIS." ACCORDING TO THE LITERATURE, AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSDUODENAL TO GALLBLADDER FOR THE TREATMENT OF ACUTE CHOLECYSTITIS DURING AN ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, NO DRAINAGE OF BILE WAS OBSERVED. IT WAS CONFIRMED UNDER FLUOROSCOPY THAT THE DISTAL FLANGE WAS DEPLOYED BETWEEN THE DUODENUM AND GALLBLADDER. A GUIDEWIRE WAS THEN ADVANCED THROUGH THE LUMEN-APPOSING METAL STENT AND THREE 10F-3CM AND TWO 7F-3CM DOUBLE PIGTAIL PLASTIC STENTS WERE SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT AND THE PATIENT LIVED UNEVENTFULLY FOR 6 MONTHS. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TRANSDUODENAL TO GALLBLADDER. 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 A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH >= 70 % FLUID CONTENT. THE DEVICE IS NOT INDICATED TO BE IMPLANTED IN THE GALLBLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516734 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553570 0027516261

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention