BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057

    MDR report key: 1884912 · Received October 28, 2010

    Report

    Report Number
    3005099803-2010-04543
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENT IMPLANTED IN 2009. (B)(4) - CHOLANGITIS DUE TO BILIARY OBSTRUCTION; NON-SURGICAL MEDICAL INTERVENTION REQURIED. STENT MIGRATION. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS IMPLANTED INTO THE PATIENT IN (B)(6) OF 2009. ON (B)(6) 2010, THE PATIENT PRESENTED WITH CHOLANGITIS DUE TO BILIARY OBSTRUCTION, AND WAS SUBSEQUENTLY HOSPITALIZED. DURING AN ERCP PROCEDURE ON (B)(4) 2010, THE PHYSICIAN NOTED THAT THE STENT HAD MIGRATED PROXIMALLY INTO THE COMMON BILE DUCT. THOUGH IT WAS REPORTEDLY A DIFFICULT PROCEDURE, THE STENT WAS REMOVED FROM THE PATIENT, COMPLETELY IN TACT, USING RAT TOOTH FORCEPS. NO FURTHER MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS REPORTED TO BE DOING WELL POST-STENT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057 CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570530

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention