BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX BILIARY

    MDR report key: 21043487 · Received December 30, 2024

    Report

    Report Number
    3005099803-2024-06559
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    December 1, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    UDI-DI
    08714729787327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS UNDER THE AGE OF 18. BLOCK B3: EXACT EVENT DATE IS UNKNOWN; EVENT OCCURRED 48 HOURS POST STENT PLACEMENT PROCEDURE. BLOCK G4: PREMARKET/510(K): K101314, K203162; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT OF A PEDIATRIC PATIENT TO TREAT AN ANASTOMOTIC STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. FORTY-EIGHT HOURS AFTER THE STENT PLACEMENT PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND REPORTED EXPERIENCING PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, AND IT WAS NOTED THAT THE PATIENT HAD PERFORATION. THE STENT WAS ALSO NOTED TO HAVE MIGRATED THROUGH THE DUODENAL WALL. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE AFTER UNDERGOING A REINTERVENTION PROCEDURE TO CLOSE THE PERFORATION. IN THE PHYSICIAN'S ASSESSMENT, THE DUODENAL PERFORATION IS RELATED TO THE STENT. THE PATIENT IS EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945602 ADVANIX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00534230 0032193328 08714729787327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization| R