BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1970518 · Received January 25, 2011

    Report

    Report Number
    3005099803-2011-00208
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED 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 RX FULLY COVERED STENT WAS IMPLANTED WITHIN THE DISTAL COMMON BILE DUCT OF A PATIENT, ON (B)(6), 2010 AS PART OF THE (B)(4) WALLFLEX BILIARY FC BENIGN STRICTURE STUDY CLINICAL TRIAL. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS DIAGNOSED WITH CHRONIC PANCREATITIS IN 1999. ON (B)(6) 2010 A PRE-STUDY STENT PLACEMENT CHOLANGIOGRAM REVEALED A DISTAL BILIARY STRICTURE. ON (B)(6), 2010 LIVER FUNCTION TESTS WERE PERFORMED AND RECORDED. A SPHINCTEROTOMY WAS PERFORMED PRIOR TO THIS PROCEDURE AND THE STRICTURE HAD BEEN PREVIOUSLY DILATED WITH ONE PLASTIC STENTS. THE PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED PRIOR TO STUDY STENT PLACEMENT PROCEDURE. A SPHINCTEROTOMY WAS NOT PERFORMED DURING THE STUDY STENT PLACEMENT PROCEDURE. ON (B)(6), 2010, THE 10 MM X 40 MM STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. THE PATIENT WAS TREATED AS AN INPATIENT AND DISCHARGED ON (B)(6), 2010. ON JANUARY 10, 2011 THE PATIENT UNDERWENT PER PROTOCOL STENT REMOVAL WITH NO REPORTED ISSUES. A POST STENT REMOVAL EXAMINATION REVEALED A RECURRENT STRICTURE. A NEW STENT WAS THEN PLACED IN THE PATIENT LATER THAT DAY.

    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 M00570820 0013054979

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR