BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2040137 · Received April 5, 2011

    Report

    Report Number
    3005099803-2011-01121
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, 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 MID 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 HAD PREVIOUSLY UNDERGONE A CHOLECYSTECTOMY IN 1997. ON (B)(6) 2010, NO SYMPTOMS WERE NOTED ON THE BASELINE BILIARY OBSTRUCTIVE SYMPTOMS ASSESSMENT. LIVER FUNCTION TESTS WERE PERFORMED AND RECORDED. A PRE-STUDY STENT PLACEMENT CHOLANGIOGRAM REVEALED A MID BILIARY STRICTURE. A SPHINCTEROTOMY WAS PERFORMED PRIOR TO THIS PROCEDURE, BUT NOT DURING THE PROCEDURE, AS THE STRICTURE HAD BEEN PREVIOUSLY DILATED WITH ONE PLASTIC STENT. THE PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED PRIOR TO STUDY STENT PLACEMENT. THE 10 MM X 60 MM STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. THE PATIENT WAS TREATED AS AN OUTPATIENT. ON (B)(6) 2011, (B)(6) POST STENT PLACEMENT, THE PATIENT UNDERWENT A PER PROTOCOL STENT REMOVAL PROCEDURE. DURING THE REMOVAL PROCEDURE IT WAS DISCOVERED THAT THE STENT HAD MIGRATED PROXIMALLY. THE STENT WAS ABLE TO BE REMOVED WITH DIFFICULTY; HOWEVER THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS REPORTED TO BE "FINE" POST PROCEDURE.

    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 13142318

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR