BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 18163252 · Received November 17, 2023

    Report

    Report Number
    3005099803-2023-06210
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 25, 2023
    Report Date
    November 17, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A150207 CAPTURES THE REPORTABLE EVENT OF STENT DIFFICULT TO REMOVE. IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE. IMDRF DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT MATERIAL DEFORMATION. IMDRF DEVICE CODE A090814 CAPTURES THE REPORTABLE EVENT OF STENT NOT VISIBLE UNDER EUS OR FLUOROSCOPY. IMDRF IMPACT CODE F2301 CAPTURES THE STENT WAS ATTEMPTED TO BE REMOVED USING FORCEPS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX FULLY COVERED BILIARY STENT RMV WAS IMPLANTED TO TREAT A BENIGN ANASTOMOSIS DUE TO LIVER TRANSPLANT IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT. DURING STENT REMOVAL PROCEDURE, THE STENT ATTEMPTED TO BE REMOVED USING FORCEPS; HOWEVER, THE STENT WAS UNABLE TO BE REMOVED DUE TO LOSS OF COVERAGE AND IT WAS NOTED THAT THERE WAS AN INGROWTH OF TISSUE OF THE EXPOSED COVER. ANOTHER STENT WAS IMPLANTED, AND ANOTHER ATTEMPT OF STENT REMOVAL WILL BE PERFORMED IN FOUR WEEKS. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636884 WALLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00570490 0029714012

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention