BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 4231279 · Received November 6, 2014

    Report

    Report Number
    3005099803-2014-03569
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 STENT WAS IMPLANTED IN THE COMMON BILE DUCT DURING A BILIARY STENTING PROCEDURE PERFORMED APPROXIMATELY THREE MONTHS PRIOR TO (B)(6) 2014. THERE WERE NO ISSUES DURING THE STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE STENT WAS TO BE REMOVED AND REPLACED DUE TO RECURRENT STENOSIS AND GROWTH OF THE AMPULLOMA. DURING THE PLANNED STENT REMOVAL PROCEDURE, THE PHYSICIAN REMOVED THE AMPULLOMA AND ATTEMPTED TO REMOVE THE STENT. HOWEVER, AFTER A FEW ATTEMPTS, THE STENT COULD NOT BE REMOVED. THE STENT WAS LEFT IN PLACE AND ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED WITHIN THE FIRST STENT TO RESTORE THE BILIARY DRAINAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714340 WELLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK475

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention