BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1813389 · Received August 24, 2010

    Report

    Report Number
    3005099803-2010-03668
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    February 2, 2010
    Report Date
    August 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):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 TO TREAT A BENIGN ANASTOMOTIC STRICTURE WITHIN THE PROXIMAL PART OF THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2009, A PLASTIC STENT WAS REMOVED AFTER A 3 MONTH IMPLANTATION PERIOD. ON THE SAME DAY, THE WALLFLEX BILIARY RX COVERED STENT WAS PLACED WITHIN THE PATIENT'S COMMON BILE DUCT TO TREAT THE STRICTURE. DURING THE SCHEDULED REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010, IT WAS NOTED THAT THE STENT HAD MIGRATED PROXIMALLY (ABOVE THE STRICTURE). THE STENT WAS REMOVED WITHOUT TECHNICAL COMPLICATIONS USING A PAIR OF RAT TOOTH FORCEPS AND A RETRIEVAL BALLOON. IT WAS NOTED THAT THE ANASTOMOTIC STRICTURE HAD RESOLVED AND THAT NO RE-STENTING WAS NECESSARY.

    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 M00570510

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR RAT TOOTH FORCEPS| RETRIEVAL BALLOON