BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 13266322 · Received January 17, 2022

    Report

    Report Number
    3001845648-2022-00021
    Event Type
    Malfunction
    Date Received
    January 17, 2022
    Date of Event
    December 21, 2021
    Report Date
    October 7, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002506241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. THE INVESTIGATION IS IN PROGRESS AND A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. THE INVESTIGATION IS IN PROGRESS AND A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K163018. DEVICE EVALUATION: THE ZILBS-635-10-8 DEVICE OF LOT NUMBER C1857198 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 15TH MARCH 2022. IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION: VISUAL INSPECTION: RED SAFETY LOCK NOT RETURNED. STENT IS PARTIALLY DEPLOYED ON RETURN AND EXPOSED PART OF THE STENT APPEARS TO BE DAMAGED. NO KINKS OR DAMAGE TO THE OUTER SHEATH. FUNCTIONAL INSPECTION:0.035 INCH WIRE GUIDE PASSED WITH NO ISSUES; DEVICE FLUSHED WITH NO ISSUE; STENT DEPLOYED WITH NO ISSUE. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ZILBS-635-10-8 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZILBS-635-10-8 OF LOT NUMBER C1857198 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1857198. THE INSTRUCTIONS FOR USE (IFU0065) INSTRUCTS THE USER TO INSPECT THE DEVICE ON REMOVAL FROM THE PACKAGING:¿ UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO TORTUOUS ANATOMY WHICH MAY HAVE COMPRESSED OR ROTATED THE DELIVERY SYSTEM AS IT ADVANCED AND PREVENTED THE STENT FROM BEING DEPLOYED. STENT WAS PARTIALLY DEPLOYED ON RETURN AND EXPOSED PART OF THE STENT APPEARED TO BE DAMAGED, LIKELY BUILD UP PRESSURE. IT MAY BE NOTED THAT RETURNED DEVICE FUNCTIONED AS INTENDED. AS PER ADDITIONAL INFORMATION PROVIDED; "SAID HE TRIED TO DEPLOY THE STENT AFTER DILATION AND SPHINCTEROTOMY, STENT IS GONE INSIDE THE CBD OVER THE WIRE WITH RESISTANCE , ENDOSCOPY NURSE TRIED TO DEPLOY THE STENT ONCE THE STENT CROSS THE TARGETED POSITION , NOT ABLE TO DEPLOY THE STENT , SEEN RESISTANCE WHILE DEPLOYING , SO TAKEN OUT THE STENT WITHOUT GIVING MORE PRESSURE TO THE STENT ,NOTICED THAT FIRST FEW CELLS ( STENT BODY ) IS OPENED .STENT IS PARTIALLY OPENED WHILE TAKING OUT FROM THE PATIENT , FINISHED CASE BY DEPLOYED ANOTHER ZILVER" SUMMARY. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, A PLASTIC STENT WAS PLACED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    DISTAL CBD STRICTURE AFTER CANNULATION MILD SPHINCTEROTOMY AND DILATION THE CBD WITH 9FRSBDC, ZILBS-635-10-8 TRIED TO DEPLOYED STENT GONE INSIDE BUT FEEL RESISTANCE WHILE DEPLOYED WITHOUT GIVEN MORE PRESSURE TAKEN OUT THE STENT, SEEN 2-3 GAGES OF THE STENT NEVER OPENED. FINISHED THE CASE BY DEPLOYING ANOTHER ZILVER BILIARY METAL STENT - ZILBS-635-10-8.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF A LAB EVALUATION ON 15-MAR-2022: VISUAL INSPECTION: RED SAFETY LOCK NOT RETURNED. STENT IS PARTIALLY DEPLOYED ON RETURN AND EXPOSED PART OF THE STENT APPEARS TO BE DAMAGED. NO KINKS OR DAMAGE TO THE OUTER SHEATH.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857910 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G50624 C1857198 10827002506241

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male