BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 2143113 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02265
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    March 23, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2012: STUDY SOURCE: (B)(4) STUDY CLINICAL TRIAL. 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) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED AS PER THE (B)(4) STUDY PROTOCOL TO ASSESS THE SAFETY AND PERFORMANCE OF TEMPORARY PLACEMENT OF THE WALLFLEX BILIARY RX FULLY COVERED STENTS AS A TREATMENT OF BILIARY OBSTRUCTION RESULTING FROM BENIGN BILE DUCT STRICTURES. PAIN, FEVER, NAUSEA, CHOLANGITIS, AND STENT MIGRATION ARE LISTED IN THE DFU FOR THIS PRODUCT AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THIS DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    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 RX BILIARY FULLY COVERED STENT WAS IMPLANTED ON (B)(6) 2010, AS PART OF THE (B)(4) STUDY CLINICAL TRIAL. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A LIVER TRANSPLANT ON (B)(6) 2010. ON (B)(6) 2010, A BASELINE BILIARY OBSTRUCTIVE SYMPTOMS ASSESSMENT WAS PERFORMED AND REVEALED THE SYMPTOMS OF RIGHT UPPER QUADRANT PAIN, FEVER/CHILLS, JAUNDICE, AND PALE STOOLS. IN ADDITION, LIVER FUNCTION TESTS WERE PERFORMED AND THE RESULTS WERE RECORDED. ON (B)(6) 2010, A PRE-STUDY STENT CHOLANGIOGRAM REVEALED A MID-BILIARY STRICTURE. A SPHINCTEROTOMY WAS NOT PERFORMED DURING THE STUDY STENT PLACEMENT PROCEDURE AS A SPHINCTEROTOMY HAD PREVIOUSLY BEEN PERFORMED. IN ADDITION, THE STRICTURE HAD BEEN PREVIOUSLY DILATED WITH ONE PLASTIC STENT AND BALLOON. THE PREVIOUSLY PLACED PLASTIC STENT WAS NOT REMOVED PRIOR TO STUDY STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. THE SUBJECT WAS TREATED AS AN INPATIENT. ON (B)(6) 2010, THE SUBJECT WAS DISCHARGED. ON (B)(6) 2011, DURING THE PER PROTOCOL STENT REMOVAL, THE SITE NOTED THAT THE STENT HAD MIGRATED. THE SITE CONFIRMED THE DEVICE MALFUNCTION. A PRE-STUDY STENT REMOVAL CHOLANGIOGRAM HAD SHOWED THE STENT TO BE IN A SATISFACTORY POSITION BRIDGING THE STRICTURE. ADDITIONAL INFORMATION SINCE (B)(4) 2012: FOLLOWING REMOVAL OF THE STUDY STENT ON (B)(6) 2011, NO RESIDUAL ANASTOMOTIC STRICTURE NOTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED FEVER (39.6 DEGREES C), CHILLS, AND NAUSEA WITH NO VOMITING. THE PATIENT ALSO EXPERIENCED ABDOMINAL PAIN IN THE EPIGASTRIC REGION WITH RADIATION TO THE LOWER ABDOMEN AND OCCASIONAL CRAMPS. LIVER ENZYMES WERE AS FOLLOWS: ALKALINE PHOSPHATASE = 116 IU/L, GAMMA GT = 360 IU/L, SGOT (AST) = 103 IU/L AND SGPT (ALT) = 231 IU/L. THE PATIENT WAS DIAGNOSED WITH CHOLANGITIS. ACCORDING TO THE COMPLAINANT, ULTRASOUND WAS UNREMARKABLE, AMYLASE WAS NORMAL, AND THERE WERE NO INDICATIONS OF PANCREATITIS OR PNEUMONIA. THE CHOLANGITIS WAS TREATED WITH ANTIBIOTIC MEDICATION. THE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2011. THE ADJUDICATION RESULTS ASSESSED THE EVENT OF CHOLANGITIS AS RELATED TO THE STUDY STENT AND THE STUDY STENT REMOVAL AS THE EVENT OCCURRED ONE DAY FOLLOWING THE STUDY STENT REMOVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX RX BILIARY FULLY COVERED STENT WAS IMPLANTED 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 A LIVER TRANSPLANT ON (B)(6), 2010. ON (B)(6), 2010, A BASELINE BILIARY OBSTRUCTIVE SYMPTOMS ASSESSMENT WAS PERFORMED AND REVEALED THE SYMPTOMS OF RIGHT UPPER QUADRANT PAIN, FEVER/CHILLS, JAUNDICE, AND PALE STOOLS. IN ADDITION, LIVER FUNCTION TESTS WERE PERFORMED AND THE RESULTS WERE RECORDED. ON (B)(6), 2010, A PRE-STUDY STENT CHOLANGIOGRAM REVEALED A MID-BILIARY STRICTURE. A SPHINCTEROTOMY WAS NOT PERFORMED DURING THE STUDY STENT PLACEMENT PROCEDURE AS A SPHINCTEROTOMY HAD PREVIOUSLY BEEN PERFORMED. IN ADDITION, THE STRICTURE HAD BEEN PREVIOUSLY DILATED WITH ONE PLASTIC STENT AND BALLOON. THE PREVIOUSLY PLACED PLASTIC STENT WAS NOT REMOVED PRIOR TO STUDY STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. THE SUBJECT WAS TREATED AS AN INPATIENT. ON (B)(6), 2010, THE SUBJECT WAS DISCHARGED. ON (B)(6), 2011, DURING THE PER PROTOCOL STENT REMOVAL, THE SITE NOTED THAT THE STENT HAD MIGRATED. THE SITE CONFIRMED THE DEVICE MALFUNCTION. A PRE-STUDY STENT REMOVAL CHOLANGIOGRAM HAD SHOWED THE STENT TO BE IN A SATISFACTORY POSITION BRIDGING THE STRICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570830 0013048532

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention