BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 16552630 · Received March 16, 2023

    Report

    Report Number
    3001845648-2023-00173
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 23, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002519333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P050017/S006. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P050017/S006 DEVICE EVALUATION THE ZFV6-80-10-8.0 DEVICE OF LOT NUMBER C1905086 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. AN ADDITIONAL PR 393859 HAS BEEN RAISED TO CAPTURE THE OFF LABEL USE OF THE REPLACEMENT DEVICE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE (B)(6) 2023. REFER TO THE RETURNED PRODUCT-NOTES FIELD FOR LAB ATTENDANCE AND LAB EVALUATION NOTES. THE RETURNED DEVICE LAB EXAMINATION FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH ATTACHED PHOTOS. ON EVALUATION OF THE DEVICE THE FOLLOWING WAS NOTED: VISUAL INSPECTION: ¿ RED SAFETY TAB NOT RETURNED. ¿ OUTER SHEATH SEPARATED FROM HANDLE. ¿ STENT NOT RETURNED. FUNCTIONAL INSPECTION: ¿ DEVICE FLUSHED WITH NO ISSUE. ¿ 0.035" WIRE GUIDE PASSED WITHOUT ISSUE. ¿ MANUALLY ATTEMPTED TO DEPLOY STENT, STENT NOT RETURNED. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY A REVIEW OF THE MANUFACTURING RECORDS 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 FOR THIS WORK ORDER. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿THE PRODUCT IS INTENDED FOR USE IN THE ILIAC, SUPERFICIAL FEMORAL ARTERY (SFA) AND ABOVE THE KNEE POPLITEAL ARTERY¿. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM THE INFORMATION RECEIVED IT IS KNOWN THAT THE STENT WAS USED IN THE LIVER DURING A TIPSS PROCEDURE. THIS IS NOT THE INTENDED AREA OF USE AS SPECIFIED IN THE IFU. ALSO, IT SHOULD BE NOTED THAT SECONDARY TO THE OFF LABEL USE, A 9 FR ACCESS SHEATH WAS USED. INSTRUCTIONS FOR USE RECOMMEND THE USE OF AN ACCESS SET THAT ACCEPTS A 6.0 FRENCH (2.0MM) INTRODUCER CATHETER. THE USE OF A LARGER SIZE ACCESS SHEATH WOULD NOT HAVE CONTRIBUTED TO THE SHEATH SNAPPING AT THE STENT PLACEMENT STAGE. IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. THE STENT WAS USED IN THE LIVER DURING A TIPSS PROCEDURE. THIS IS NOT THE INTENDED AREA OF USE AS SPECIFIED IN THE IFU. AS THE PRODUCT HAS NOT BEEN TESTED IN THIS AREA, IT IS UNKNOWN HOW THE DEVICE THE PERFORM OR FUNCTION. THIS UNINTENDED USE COULD HAVE CAUSED RESISTANCE OR EXCESSIVE FORCE TO BE USED WHICH COULD IN TURN COULD HAVE CAUSED THE SHEATH TO SNAP. OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. AS THE DEVICE WAS USED OUTSIDE OF THEIR VALIDATED STATE AND/OR AGAINST THE INSTRUCTIONS PROVIDED IN THE IFU, IT IS NOT POSSIBLE TO PREDICT HOW THE DEVICES WILL PERFORM OR FUNCTION. ALSO, IT SHOULD BE NOTED THAT SECONDARY TO THE OFF LABEL USE, A 9 FR ACCESS WAS USED. INSTRUCTIONS FOR USE RECOMMEND THE USE OF AN ACCESS SET THAT ACCEPTS A 6.0 FRENCH (2.0MM) INTRODUCER CATHETER. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. AN ADDITIONAL STENT WAS PLACED ON THE TARGET LESION IN THE SAME PROCEDURE TO COMPLETE THE TREATMENT. PR (B)(4) (EMDR REF.- 3001845648-2023-00247) WILL CAPTURE THE OFF LABEL PLACEMENT OF THIS SUCCESSFUL STENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE STENT PLASTIC SHEATH SNAPPED. TYPE OF PROCEDURE TIPSS LIVER.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP MDR REPORT IS BEING SUBMITTED DUE TO THE LAB EVALUATION BEING COMPLETED ON (B)(6) 2023 AND ADDITIONAL INFORMATION RECEIVED ON 13-APR-2023. REPORT ALSO BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2023 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS. ADDITIONAL INFORMATION RECEIVED AS FOLLOW: 1. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO 2. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR? STENT PLACEMENT. 3. DETAILS OF ACCESS SHEATH USED (NAME, FR SIZE, LENGTH)? CHECKFLO 9FR, 13CM 4. WHAT WAS THE TARGET LOCATION FOR THE STENT? PORTAL VEIN TO HEPATIC VEIN 5. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? YES 6. WAS THE DEVICE USED PERCUTANEOUSLY? YES 7. WAS THE DEVICE FLUSHED THROUGH BOTH FLUSHING PORT BEFORE THE PROCEDURE, AS PER IFU? YES 8. WAS PRE-DILATION PERFORMED AHEAD OF PLACEMENT OF THE STENT? YES 9. WAS POST-DILATION PERFORMED AFTER THE PLACEMENT OF THE STENT? NO 10. DETAILS OF THE WIRE GUIDE USED (NAME, DIAMETER, HYDROPHILIC)? AMPLATZ EXTRA STIFF GUIDE WIRE, 0.035" 260CM ANGLED 11. DID THE PATIENT EXHIBIT DIFFICULT OR ALTERED ANATOMY (IF ALTERED PLEASE SPECIFY HOW IT IS ALTERED)? N/A 12. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO 13. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NO 14. HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? N/A 15. WAS THE APPROACH IPSILATERAL OR CONTRALATERAL? JUGULAR 16. IF CONTRALATERAL, WAS THE BIFURCATION ANGLE STEEP? N/A 17. DID THE TIP OF THE DELIVERY SYSTEM CROSS THE TARGET LOCATION? YES 18. WAS THE DELIVERY SYSTEM TRACKED AROUND A TIGHT ANGLE IN THE PATIENT ANATOMY? N/A 19. WAS THE DELIVERY SYSTEM DAMAGED/KINKED/TWISTED DURING DEPLOYMENT? YES 20. WAS THE HANDLE PULLED TOWARDS THE HUB DURING DEPLOYMENT? YES 21. WAS THE DELIVERY SYSTEM PUSHED DURING DEPLOYMENT? N/A 22. WAS THE STENT DEPLOYED SMOOTHLY / WITHOUT RESISTANCE? NO 23. IF NO, PLEASE DETAIL ANY DIFFICULTY EXPERIENCED DURING DEPLOYMENT: THE SHEATH SNAPPED FROM THE PLUNGE WHILE DEPLOYING 24. WHAT ARTERY WAS THE STENT PLACED IN? N/A 25. WAS THE STENT FULLY DEPLOYED FROM THE DELIVERY SYSTEM PRIOR TO REMOVAL OF THE DELIVERY SYSTEM? NO 26. DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS? NO 27. IF YES, PLEASE SPECIFY: __________________________ 28. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? DEPLOYED ANOTHER STENT OF SIZE ZFV6-125-10-6.0 29. WHAT INTERVENTION (IF ANY) WAS REQUIRED? DEPLOYED ANOTHER STENT OF SIZE ZFV6-125-10-6.0 30. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME PROCEDURE 31. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM PRIOR TO RETURN (E.G. KINK)? N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828484 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD C1905086 10827002519333

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male