BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 10424594 · Received August 19, 2020

    Report

    Report Number
    3001845648-2020-00509
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    April 20, 2010
    Report Date
    July 16, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K163018. THE ZILVER 635 BILIARY SELF EXPANDING METAL STENT DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENTS AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER 635 BILIARY SELF EXPANDING METAL STENT DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0065-3). IT SHOULD BE NOTED THAT STENT OCCLUSION IS LISTED AS AN ADDITIONAL ADVERSE EVENT THAT CAN OCCUR WITH BILIARY STENT PLACEMENT WITHIN THE INSTRUCTIONS FOR USE (IFU0065-3). A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE PAPER INDICATES THAT OCCLUSION WAS CAUSED BY MUCUS/SLUDGE FORMATION AND TUMOR INGROWTH. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/UNDERLYING CONDITIONS. OF THE ENTIRE SUBJECT GROUP, IT IS KNOWN THAT PRE-EXISTING CONDITIONS INCLUDED CHOLANGIOCARCINOMA, METASTATIC COLON CANCER, LUNG CANCER AND PANCREATIC CANCER. IT SHOULD ALSO BE NOTED THAT STENT OCCLUSION IS LISTED AS AN ADDITIONAL ADVERSE EVENT THAT CAN OCCUR WITH BILIARY STENT PLACEMENT WITHIN THE INSTRUCTIONS FOR USE. COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, ALL THE PATIENTS REQUIRED AN ADDITIONAL INTERVENTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE INVESTIGATION WAS CONCLUDED ON THE 16-JUL-2021, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K163018. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. [(B)(4)].

    Description of Event or Problem · 1

    CHENNAT & WAXMAN 2010 'INITIAL PERFORMANCE PROFILE OF A NEW 6F SELF-EXPANDING METAL STENT FOR PALLIATION OF MALIGNANT HILAR BILIARY OBSTRUCTION' PROCEDURE: AFTER OBTAINING A CHOLANGIOGRAM, A 0.035-MM SOFT JAGWIRE (BOSTON SCIENTIFIC, NATICK, MASS) WAS INTRODUCED INTO THE SELECTED SYSTEM DESIRED FOR DRAINAGE (FIG. 2). BILIARY DILATION WAS PERFORMED AS NEEDED TO FACILITATE STENT PLACEMENT. UNILATERAL VERSUS BILATERAL DRAINAGE WAS INTENDED BASED ON MRCP AND ERC FINDINGS AND THE PRESENCE OF A PREVIOUS PERCUTANEOUS TRANSHEPATIC BILIARY DRAIN (PTBD) OR METAL BILIARY STENT. THE CURRENT COMMERCIALLY AVAILABLE ITERATION OF THE 6F ZILVER 635 BILIARY STENT SYSTEM (COOK MEDICAL) IS 200 CM LONG AND AVAILABLE IN DIAMETERS OF 6, 8, AND 10 MM AND STENT LENGTHS OF 4, 6, AND 8 CM. IN CASES IN WHICH BILATERAL DRAINAGE WAS DESIRED, A ZILVER 635 BILIARY UNCOV-ERED METAL STENT DEPLOYMENT SYSTEM WAS SEQUENTIALLY IN-TRODUCED OVER THESE GUIDEWIRES INTO THE LEFT AND RIGHT COMMON HEPATIC DUCTS IN SIDE-BY-SIDE FASHION (FIG. 3). THE PROXIMAL RELEASING STENTS WERE THEN CAREFULLY DEPLOYED ACROSS THE STRICTURES, IN ALTERNATING/SEQUENTIAL FASHION BE-TWEEN THE LEFT AND RIGHT SIDES UNTIL FULL DEPLOYMENT WAS ACHIEVED (FIG. 4). ONCE BOTH STENTS WERE FULLY DEPLOYED, THE INTRODUCTION SYSTEMS WERE RECONSTRAINED AND EX-CHANGED OUT OF THE ENDOSCOPE OVER THEIR RESPECTIVE GUIDE-WIRES. IF THE DISTAL ENDS OF THE STENTS DID NOT BRIDGE THE AMPULLA, A SECOND SET OF SHORTER STENTS WERE DEPLOYED OVER THE RESPECTIVE RIGHT AND LEFT WIRES FOR POTENTIAL FUTURE TRANSPAPILLARY ACCESS TO EACH SIDE OF THE LIVER. ADVERSE EVENT: STENT OCCLUSION WAS DEFINED AS PERSISTENT OR RECURRENT JAUNDICE WITH CHOLESTASIS AND/OR CHOLANGITIS. ONE EARLY (6%) AND 3 LATE (19%) STENT OCCLUSIONS REQUIRED SUBSEQUENT PTBD (ALL 3 WERE LATE OCCLUSION PATIENTS) AND ERC PLASTIC 7F BILATERAL STENT INSERTIONS WITHIN THE SEMS (FOR THE 1 EARLY OCCLUSION PATIENT). THE EARLY OCCLUSION WAS CAUSED BY MUCUS/SLUDGE FORMATION, AND THE DELAYED OCCLUSIONS WERE CAUSED BY TUMOR INGROWTH, WHICH WAS UN-ABLE TO BE DRAINED ENDOSCOPICALLY BASED ON SUBSEGMENTAL INTRAHEPATIC BILIARY LOCATIONS AND THUS REQUIRED PTBD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889739 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention