BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    MDR report key: 4019360 · Received July 16, 2014

    Report

    Report Number
    3001845648-2014-00131
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 19, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K040505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510K NUMBERS: K043481, K051124. THIS INCIDENT REQUIRES AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR STENT FRACTURE FOR THIS PRODUCT FAMILY; REGARDLESS OF PATIENT OUTCOME. CONFIRMATION WAS RECEIVED THAT THE SECOND ZILVER BILIARY STENT DEPLOYED DURING THE PROCEDURE FRACTURED. THE SPECIFIC RPN OF THIS SECOND STENT COULD NOT BE CONFIRMED HOWEVER TWO POSSIBLE RPN'S WERE PROVIDED AS FOLLOWS: ZIB6-40-6.0-40 OF LOT NUMBER C872609 OR ZIB6-40-8.0-60 OF LOT NUMBER C930166. THERE WERE NO ZIB6-40-6.0-40 DEVICES OF LOT NUMBER C872609 OR ZIB6-40-8.0-60 DEVICES OF LOT NUMBER C930166 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. A DOCUMENTATION BASED INVESTIGATION WAS CARRIED OUT AS THE DEVICE INVOLVED WAS NOT AVAILABLE FOR EVALUATION. THE STENT WAS IMPLANTED AND REMAINS IN THE PATIENT. X-RAY IMAGES RELATING TOT HIS INCIDENT WERE RECEIVED AND REVIEWED. UPON THIS IMAGE REVIEW A STENT FRACTURE WAS NOTED AND THE CUSTOMER COMPLAINT WAS CONFIRMED. IT WAS CONFIRMED THAT THE STENTS USED WERE 6MM AND 8MM IN DIAMETER. IT IS POSSIBLE THAT IF THE SMALLER DIAMETER STENT WAS PLACED FIRST THEN THERE WAS LESS ROOM FOR THE INTRODUCER TO PASS THROUGH THE MESH. THE USER WOULD HAVE BEEN TRYING TO OPEN A LARGER STENT THROUGH THE MESH OF A SMALLER STENT WHICH COULD PUT POINT LOADING FORCES ON THE STRUTS OF THE SECOND STENT POSSIBLY LEADING TO STENT FRACTURE. IT MAY BE NOTED THAT ACCORDING TO INFORMATION PROVIDED BY THE USER IT CANNOT BE DETERMINED WHICH STENT RPN WAS PLACED FIRST THEREFORE THIS POSSIBLE CAUSE OF THE STENT FRACTURE CANNOT BE CONFIRMED. IT IS ALSO POSSIBLE THE DELIVERY SYSTEM OF THE SECOND STENT MAY HAVE DAMAGED THE FIRST STENT PLACED. IT IS ALSO FURTHER NOTED THAT THE STENTING PROCEDURE INVOLVED 'STENT-IN-STENT' TECHNIQUE. STENTING THROUGH THE WALL OF THE PREVIOUSLY DEPLOYED STENT COULD ALSO HAVE RESULTED IN THIS STENT FRACTURE. THE DEVICE INVOLVED INT HIS COMPLAINT WAS NOT RETURNED FOR EVALUATION AND THE CONDITIONS OF DEVICE USE CANNOT BE REPLICATED IN THE LABORATORY SETTING. A DEFINITIVE CAUSE OF THE STENT FRACTURE AND SUBSEQUENT MIGRATION CANNOT BE CONCLUSIVELY DETERMINED. THE FOLLOWING COMMENTS WERE PROVIDED BY THE PHYSICIAN INVOLVED IN THIS COMPLAINT: "... SINCE THE STENOSED AREA WAS TREATED WITH THE STENTS AND PATENCY IS SECURED, I THINK THAT FRACTURE ITSELF IS NOT SUCH A BIG PROBLEM." THE FRACTURED STENT REMAINS IN THE PATIENT. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. PRIOR TO DISTRIBUTION ALL ZILVER 635 BILIARY SELF-EXPANDING STENT SYSTEMS ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE OVERALL RISK ASSOCIATED WITH THIS INCIDENT WAS DETERMINED TO BE CATEGORY III (LOW). QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE PHYSICIAN HAD PLANNED A STENT PLACEMENT IN THE HEPATIC PORTAL REGION WITH STENT-IN STENT TECHNIQUE MAKING A Y SHAPE WITH THE STENTS. TWO ZILVER BILIARY STENT DEVICES WERE SELECTED. THE FIRST STENT WAS DEPLOYED AND PLACED FROM THE RIGHT HEPATIC BILE DUCT TO THE COMMON HEPATIC DUCT. THEN, THE SECOND STENT WAS DEPLOYED AND PLACED FROM THE LEFT HEPATIC BILE DUCT TO THE COMMON HEPATIC DUCT THROUGH THE MESH OF THE FIRST STENT. RESISTANCE WAS NOTED WHEN ADVANCING THE DELIVERY SYSTEM. ANGIOGRAPHY FOLLOWING THE PROCEDURE CONFIRMED THAT THE SECOND STENT WAS FRACTURED AND HAD SEPARATED IN TWO. ONE OF THE SEPARATED SEGMENTS HAD SIGNIFICANTLY MIGRATED DOWNWARDS BENEATH THE FIRST STENT. THE PHYSICIAN DID NOT CONDUCT ANY ADDITIONAL TREATMENT AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416075 ZILVER 635 SELF-EXPANDING BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD C872609

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK