BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 14712495 · Received June 16, 2022

    Report

    Report Number
    3001845648-2022-00361
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 20, 2022
    Report Date
    August 5, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002519173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 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 ZFV6-80-9-4.0 DEVICE OF LOT NUMBER C1899061 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 THE (B)(6)2022. REFER TO ATTACHMENTS ¿ZILVER LAB EVALUATIONS ATTENDANCE (B)(6) 2022¿ FOR LAB ATTENDANCE . ON EVALUATION OF THE DEVICE, IT WAS FOUND THAT THE RED SAFETY TAB WAS RETURNED IN PLACE. THE STENT WAS RETURNED SEPARATELY INTACT. NO OTHER DEFECTS WERE FOUND. THE DEVICE FLUSHES AS INTENDED AND A 0.035¿ WIRE GUIDE PASSED THROUGH THE DEVICE WITH NO ISSUE. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZFV6-80-9-4.0 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 ZFV6-80-9-4.0 OF LOT NUMBER C1899061 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 C1899061. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE, IFU0058. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DAMAGE TO THE DEVICE CAUSED BY IMPACT DURING SHIPPING. IT IS POSSIBLE THAT THE DEVICE WAS SUBJECTED TO IMPACT DURING TRANSPORTATION IN ITS ORIGINAL PACKAGING, WHICH MAY HAVE CAUSED COMPONENTS IN THE HANDLE OF THE DEVICE TO BECOME DAMAGED/CRACKED, WHICH MAY HAVE LED TO OR CONTRIBUTED TO THE DEPLOYMENT OF THE STENT. 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. THE DAMAGED DEVICE WAS NOT USED IN ANY PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    PRODUCT RELEASED AUTOMATICALLY WHEN OPENED THE PACKAGE. "AS PER CC FORM": WHEN THE DOCTOR OPENED THE PACKAGE, HE NOTICED THAT THE STENT WAS LOOSE IN THE PACKAGE. NO ONE HAD TOUCHED THE RELEASE SYSTEM AND THE RED LOCKING PIN WAS ALSO NORMALLY IN THE SYSTEM. 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. NO CONTACT WITH PATIENT.

    Description of Event or Problem · 0

    SUPPLEMENTAL MDR BEING SUBMITTED DUE TO LAB EVALUATION COMPLETED ON 20-JUNE-2022 LAB EVALUATION 20TH JUNE : VISUAL INSPECTION RED SAFETY TAB RETURNED IN PLACE STENT RETURNED SEPARATELY INTACT. FUNCTIONAL INSPECTION 0.035'' WIRE GUIDE PASSED THROUGH DEVICE WITH NO ISSUE. DEVICE FLUSHED AS INTENDED

    Description of Event or Problem · 0

    SUPPLEMENTAL MDR BEING SUBMITTED DUE TO COMPLETED INVESTIGATION ON 05-AUG-2022

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129224 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD C1899061 10827002519173

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown