BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 12680194 · Received October 22, 2021

    Report

    Report Number
    3001845648-2021-00734
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 18, 2021
    Report Date
    September 20, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002506234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K851962. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K851962. PR343163 WILL CAPTURE STENT PREMATURE RELEASE . PR351464 WILL CAPTURE USER ERROR. DEVICE EVALUATION: THE ZILBS-635-8-8 DEVICE OF LOT NUMBER C1773585 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 10 DECEMBER 2021. THE RETURNED DEVICE LAB EXAMINATION FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH ATTACHED PHOTOS. ON EVALUATION THE STENT WAS PARTIALLY DEPLOYED, AND STENT APPEARS CUT AT DISTAL END OF THE OUTER SHEATH (NO GOLD RIVETS VISIBLE AT THE DISTAL END OF OUTER SHEATH). ROUGHNESS OF OUTER SHEATH WAS ALSO OBSERVED FROM DISTAL WHITE TIP TO APPROX. 17,5CM ON OUTER SHEATH. DEVICE RETURNED WITHOUT RED SAFETY TAB. THERE WAS A STAINLESS-STEEL WIRE RETURNED IN THE DELIVERY SYSTEM. THE DEVICE FLUSHED WELL WITHOUT ANY ISSUES AND THE 0.035 SIZE WIRE GUIDE PASSED WITHOUT ISSUES. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZILBS-635-8-8 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ZILBS-635-8-8 OF LOT NUMBER C1773585 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO IMPACT DURING TRANSPORTATION OR STORAGE. THIS IS LIKELY SO AS THE USER NOTED THAT THE RED SAFETY TAB WAS NOT ON THE DEVICE AS WELL AS THAT THE STENT WAS PARTIALLY DEPLOYED UPON OPENING THE DEVICE PACKAGE. SUMMARY: COMPLAINT IS CONFIRMED AS 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 DEVICE EVALUATION ON 10-DEC-2021.

    Description of Event or Problem · 0

    SUPPLEMENTAL CORRECTION REPORT IS BEING SUBMITTED DUE TO THE A AND G CODES BEING UPDATED FROM A150103 TO A0204 AND G04122 TO G07001 ON 20-SEP-2023.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) #: K851962.

    Description of Event or Problem · 1

    USER OPENED THE PACKAGE AND DETECTED THERE IS 0.5CM OF STENT PREMATURE RELEASED FROM DELIVERY SYSTEM, AND RED SAFETY LOCK IS NOT ON DEVICE. NURSE TOOK SCISSORS TO CUT THE RELEASED 0.5CM STENT. USER THEN ADVANCED THE DELIVERY SYSTEM THROUGH WIRE GUIDE BUT CANNOT GET THROUGH STENOSIS AREA. USER THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. PATIENT OUTCOME : "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? ACRO-35-450 IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? WITH ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: HAD A SPHINCTEROTOMY BEEN PERFORMED PRIOR TO THIS OCCURRENCE? YES. HAD DILATION OF THE OBSTRUCTED AREA BEEN PERFORMED PRIOR TO THIS OCCURRENCE? YES. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS TF-260V. PLEASE DESCRIBE THE LOCATION IN THE BODY WHERE THE STENT WAS TO BE PLACED. COMMON BILE DUCT. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE OBSTRUCTED AREA? YES. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT AND INTRODUCER THROUGH THE OBSTRUCTED AREA? YES. WAS THE INTRODUCER ADVANCED THROUGH THE SIDE OF A PREVIOUSLY PLACED STENT? NO. PLEASE ESTIMATE AMOUNT OF TIME THE STENT WAS IN PLACE PRIOR TO THIS OCCURRENCE. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580292 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G50623 C1773585 10827002506234

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male