BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 19826971 · Received July 25, 2024

    Report

    Report Number
    3001845648-2024-00413
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 26, 2024
    Report Date
    January 23, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002518534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THIS FILE WAS OPENED IN RESPONSE TO A REPORT FROM SHENZHEN INLIFE SCI. CO.,LTD, THAT THE STENT WAS RELEASED COMPLETELY-PRIOR TO USE. DEVICE EVALUATION: THE ZFV6-125-10-8.0 DEVICE OF LOT NUMBER CF1964478 WAS RETURNED FOR EVALUATION WITH ITS ORIGINAL OPENED PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: RED SAFETY TAB RETURNED SEPARATELY DEPLOYED STENT RETURNED SEPARATELY STENT STRUTS SLIGHTLY MIS-ALIGNED AT TOP END NEAR GOLD RIVETS NO OTHER DEFECTS NOTED ON STENT HANDLE OF DELIVERY SYSTEM IN DEPLOYED POSITION KINK OBSERVED ON INNER CATHETER 6.5CM FROM WHITE DISTAL TIP FUNCTIONAL INSPECTION: DEVICE FLUSHES AS INTENDED 0.035" WIRE GUIDE PASSES THROUGH DEVICE AS INTENDED AS PREVIOUSLY NOTED, STENT WAS ALREADY DEPLOYED. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER CF1964478 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL: THERE IS NO EVIDENCE TO SUGGEST THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE DEVICE IFU0041 STATES ¿UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED¿. IMAGE REVIEW: AN IMAGE WAS RETURNED FOR EVALUATION. THE IMAGE IS OF THE DEVICE WITH A PARTIALLY DEPLOYED STENT. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO DAMAGE DURING STORAGE OR TRANSPORT OF THE DEVICE. IT IS POSSIBLE THAT THE DEVICE WAS SUBJECTED TO IMPACT DURING TRANSPORTATION IN ITS ORIGINAL PACKAGING, WHICH MAY HAVE CAUSED THE RED SAFETY TAB TO BECOME DISLODGED, WHICH MAY HAVE LED TO THE PARTIAL DEPLOYMENT OF THE STENT WHICH WAS NOTED UPON OPENING THE DEVICE PACKAGING. THE STENT WAS RETURNED FULLY DEPLOYED FROM THE DEVICE. CLARIFICATION WAS RECEIVED THAT THE STENT BECAME FULLY DEPLOYED WHILE BEING PACKAGED FOR RETURN TO COOK. THE SLIGHT MISALIGNMENT OF THE STENT STRUTS NOTED DURING THE LAB EVALUATION IS POSSIBLY A RESULT OF THE PARTIAL DEPLOYMENT DURING TRANSPORT OR STORAGE, OR THE INADVERTENT FULL DEPLOYMENT WHILE THE DEVICE WAS BEING PACKAGED FOR RETURN, ¿AFTER OPENING THE PACKAGE, THE DOCTOR FOUND THAT THE RED SAFETY LOCK OF THE STENT HAD FALLEN OFF, AND THE STENT WAS PARTIALLY RELEASED, AS SHOWN IN THE ATTACHED PICTURE. DUE TO THE LACK OF A RED SAFETY LOCK, THE ENTIRE STENT WAS RELEASED DURING THE SUBSEQUENT PROCESS OF REPACKAGING THE DELIVERY SYSTEM¿ CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED VISUAL AND/OR FUNCTIONAL INSPECTION. CORRECTIVE ACTION/ CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: THIS FILE WAS OPENED IN RESPONSE TO A COMPLAINT THAT THE STENT WAS RELEASED COMPLETELY-PRIOR TO USE. CONFIRMED QUANTITY OF 01 DEVICE PRIOR TO USE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A POSSIBLE ROOT CAUSE OF DAMAGE/IMPACT DURING STORAGE OR TRANSPORT WAS DETERMINED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: AFTER OPENING THE OUTER PACKAGE, IT WAS FOUND THAT THE RED SAFETY LOCK HAD FALLEN OFF AND THE STENT WAS RELEASED COMPLETELY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE,NO ADVERSE EFFECT REPORTED. PATIENT OUTCOME: THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE,NO ADVERSE EFFECT REPORTED

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 23-JAN-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356542 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD G51853 CF1964478 10827002518534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown