BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2040186 · Received April 5, 2011

    Report

    Report Number
    3005099803-2011-01125
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NON-SURGICAL MEDICAL INTERVENTION REQUIRED, CHOLESTASIS, DARK URINE, PALE STOOLS AND LOW GAMMA-GT LEVELS. THE REPORTED EVENT OF STENT MIGRATED. FOREIGN SOURCE: (B)(6). STUDY: (B)(4). A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED AND THE DEVICE WAS USED PER THE (B)(4) WALLFLEX FULLY COVERED BENIGN STRICTURE STUDY PROTOCOL. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS CONSIDERED TO BE AN ANTICIPATED PROCEDURAL COMPLICATION AS STENT MIGRATION IS LISTED AS A POST STENT PLACEMENT COMPLICATION IN THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    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). ACCORDING TO THE COMPLAINANT, THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH CHRONIC PANCREATITIS IN 1999. ON (B)(6), 2010, LIVER FUNCTION TESTS WERE RECORDED, AND NO BASELINE BILIARY OBSTRUCTIVE SYMPTOMS ASSESSED. A PRE-STUDY STENT PLACEMENT CHOLANGIOGRAM REVEALED A DISTAL BILIARY STRICTURE SECONDARY TO THE CHRONIC PANCREATITIS. A SPHINCTEROTOMY WAS PERFORMED PRIOR TO THIS PROCEDURE; HOWEVER A SPHINCTEROTOMY WAS NOT PERFORMED DURING THE STUDY STENT PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE STRICTURE HAD BEEN PREVIOUSLY DILATED WITH ONE PLASTIC STENT AND BALLOON. THE PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED PRIOR TO STUDY STENT PLACEMENT DURING THE STUDY STENT PLACEMENT PROCEDURE. THE 10MM X 60MM METAL STENT WAS DEPLOYED IN SATISFACTORY POSITION ACROSS THE STRICTURE AND WAS COVERING THE CYSTIC DUCT. THE SUBJECT WAS TREATED AS AN INPATIENT AND WAS DISCHARGED ON (B)(6), 2010. ON (B)(6), 2011 THE PATIENT PRESENTED TO THE HOSPITAL FOR A STENT REMOVAL PROCEDURE WITH OCCURRING SYMPTOMS OF NAUSEA, VOMITING, DARK URINE AND PALE STOOL. LAB RESULTS REVEALED LOW GAMMA-GT LEVELS AND THE PATIENT WAS DIAGNOSED WITH CHOLESTASIS. A PRE-PROCEDURE CHOLANGIOGRAM REVEALED THAT THE STENT HAD COMPLETELY MIGRATED INTO THE SIGMOID COLON. THE PATIENT HAD A RECURRENT BILE DUCT STRICTURE IN THE INITIALLY TREATED LOCATION AND WAS TREATED WITH FIVE PLASTIC STENTS. TO DATE, IT IS UNKNOWN IF THE STUDY STENT HAS BEEN EXPLANTED; HOWEVER, NO FURTHER COMPLICATIONS WERE REPORTED.

    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 M00570830 0013055455

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention