BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    MDR report key: 12630181 · Received October 14, 2021

    Report

    Report Number
    3001845648-2021-00728
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 18, 2021
    Report Date
    February 11, 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. DEVICE EVALUATION THE ZILBS-635-10-8 DEVICE OF LOT NUMBER C1802535 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED LAB EVALUATION N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZILBS-635-10-8 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-635-10-8 OF LOT NUMBER C1802535 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE PATIENT`S PRE-EXISTING CONDITIONS. IT IS KNOWN THAT THE PATIENT HAD PERIAMPULLARY CARCINOMA. IT IS POSSIBLE THAT THIS TUMOUR CONTRIBUTED TO THE STENT NOT OPENING ON DEPLOYMENT EVEN THOUGH THE PHYSICIAN STATES THAT THEY DID NOT ENCOUNTER ANY RESISTANCE. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE STENT DID NOT OPEN UP DURING DEPLOYMENT. 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. 2. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? DURING STENT PLACEMENT. 3. WAS A SPHINCTEROTOMY PERFORMED PRIOR TO USE OF THE STENT DEVICE? YES. 4. WAS BALLOON DILATION PERFORMED PRIOR TO USE OF THE STENT DEVICE? NO. 5. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? 6 CM. 6. WHAT BRAND OF ENDOSCOPE WAS USED WITH THE DEVICE? OLYMPUS . 7. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? YES. 8. WHAT WAS THE POSITION OF THE ELEVATOR DURING DEPLOYMENT? OPEN. 9. WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY OR AROUND A TIGHT ANGLE IN AN ENDOSCOPE? NO. 10. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORTS BEFORE THE PROCEDURE, AS PER IFU? YES. 11. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHYLLIC) METII-35-480. 12. WHAT WAS THE TARGET LOCATION FOR THE STENT? PERIAMPULLARY . 13. WAS THE RED SAFETY LOCK REMOVED BEFORE INSERTING THE DELIVERY SYSTEM? N/A. 14. WAS THE RED SAFETY LOCK REMOVED BEFORE STENT DEPLOYMENT? N/A. 15. WAS THE PATIENT'S ANATOMY TORTUOUS? NO. 16. DID THE PATIENT EXHIBIT ALTERED ANATOMY? NO. 17. IF YES, PLEASE SPECIFY THE TYPE OF ALTERED ANATOMY: N/A. 18. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO. 19. IF YES, HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? 20. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NO. 21. IF YES, HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? N/A. 22. WAS THERE RESISTANCE FELT PASSING THE DELIVERY SYSTEM THROUGH THE STRICTURE? NO. 23. WAS ANY DAMAGE NOTED ON THE WIRE GUIDE BEFORE, DURING OR AFTER THE PROCEDURE? NO. 24. DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? YES. 25. WAS THE HANDLE PULLED TOWARD THE HUB DURING DEPLOYMENT? YES. 26. WAS THE DELIVERY SYSTEM PUSHED DURING DEPLOYMENT? NO. 27. WAS THE STENT BEING PLACED THROUGH THE SIDE WALL OF A PREVIOUSLY PLACED STENT? NO. 28. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. 29. IF YES, WHAT INTERVENTION WAS REQUIRED? N/A. 30. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? [SAME DAY PROCEDURE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527860 ZILVER 635 BILIARY SELF EXPANDING METAL STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G50624 C1802535 10827002506241

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male