BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 3181682 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-05355
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND 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 UNCOVERED STENT WAS IMPLANTED IN THE PATIENT'S THE BILE DUCT ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, INGROWTH WAS NOTED IN THE STENT ON AN UNKNOWN DATE. A WALLFLEX BILIARY PARTIALLY COVERED STENT WAS IMPLANTED WITHIN THE STENT ON (B)(6) 2013, TO TREAT THE INGROWTH. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE SECOND STENT PLACEMENT PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283202 WELLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY UNK475

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention