BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 12513725 · Received September 22, 2021

    Report

    Report Number
    3001845648-2021-00687
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 26, 2021
    Report Date
    January 7, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002506234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # - (B)(6). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # - K182980. DEVICE EVALUATION. THE ZILBS-635-8-8 DEVICE OF LOT NUMBER C1719104 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THREE (3) ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS DEVICE. HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. IF ADDITIONAL INFO IS RECEIVED IN THE FUTURE, THEN THE FILE WILL BE UPDATED ACCORDINGLY". LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 10 DECEMBER 2021. ON EVALUATION OF THE DEVICE THE CLEAR SECTION WAS SEPARATED APPROX. 27CM -27.5CM FROM THE DISTAL END OF THE OUTER SHEATH. APPROX. 2MM OF THE STENT WAS DEPLOYED AT THE DISTAL END OF THE OUTER SHEATH. THE DEVICE FLUSHED AS EXPECTED AND THE 0.035 WIRE GUIDE SIZE PASSED WITH NO ISSUES. THE RED SAFETY LOCK WAS NOT RETURNED WITH THE DEVICE. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZILBS-635-8-8 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ZILBS-635-8-8 OF LOT NUMBER C1719104 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 C1719104. 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 DIFFICULT PATIENT ANATOMY OR IMPROPER DEVICE HANDLING. IT IS POSSIBLE THAT THIS COULD HAVE CAUSED AND/OR CONTRIBUTED TO INCREASED DEPLOYMENT FORCES ON THE FLEXOR DURING DEPLOYMENT RESULTING IN SEPARATION. IT IS POSSIBLE THAT IF THE PATIENT HAD A DIFFICULT ANATOMY IT COULD HAVE RESULTED IN COMPRESSION OF THE OUTER SHEATH DURING ADVANCEMENT OF THE DEVICE RESULTING IN PARTIAL PREMATURE DEPLOYMENT OF THE STENT. INCORRECT DEVICE HANDLING CAN EXERT EXCESSIVE PRESSURE ON THE OUTER SHEATH AND CAN RESULT IN THE SEPARATION AS WELL AS THE STENT BEING PARTIALLY DEPLOYED. IT IS ALSO POSSIBLE THAT THE RED SAFETY LOCK WAS INADVERTENTLY DISPLACED DURING ADVANCEMENT AS IT WAS NOT RETURNED WITH THE DEVICE. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE DEVICE EVALUATED (B)(6) 2021: "STENT DEPLOYED. RED SAFETY LOCK WAS NOT RETURNED ON DEVICE. OUTER SHEATH SEPARATION."

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) #: K182980.

    Description of Event or Problem · 1

    AS PER REP'S EMAIL RECEIVED ON 31/8/21, HE CONFIRMED THAT THE COMPLAINT DEVICE IS A G50623 FROM LOT NUMBER C1719104. AS PER COMPLAINT FORM, COMPLAINT DEVICE COULD POSSIBLY BE G50623, TO BE CONFIRMED. THE REP HAS JUST BEEN INFORMED OF A BROKEN SILVER 635 STENT AT ST GEORGE PUBLIC HOSPITAL. NO KEY DETAILS AT THIS STAGE. TRYING TO ENGAGE THE DEPT, BUT HAVE BEEN ADVISED IT IS HECTIC AT THE MOMENT, PRODUCT CODE COULD BE G50623 / G50620 OR G23813 LOT NUMBER TO BE ADVISED ALONG WITH MANY OTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411210 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G50623 C1719104 10827002506234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown