BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 10283698 · Received July 16, 2020

    Report

    Report Number
    3001845648-2020-00429
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    June 18, 2020
    Report Date
    October 7, 2020
    Manufacturer
    COOK INC
    Product Code
    NIO
    UDI-DI
    10827002375533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT CAN BE NOTED THAT ZIV6-125-14-8.0 IS AN E.U. PART NUMBER - ONLY APPROVED IN THE US FOR ILIAC INDICATION ONLY. AS INDICATION IS NOT CONFIRMED FDA MDR ASSESSMENT REQUIRED. PMA/510(K) # OF SIMILAR DEVICE: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    IT CAN BE NOTED THAT ZIV6-125-14-8.0 IS AN E.U. PART NUMBER - ONLY APPROVED IN THE US FOR ILIAC INDICATION ONLY. AS INDICATION IS NOT CONFIRMED FDA MDR ASSESSMENT REQUIRED. PMA/510(K) # OF SIMILAR DEVICE: P050017/S002 AND S003. DEVICE EVALUATION THE ZIV6-125-14-8.0 DEVICE OF LOT NUMBER C1721650 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 22JUL2020. THE STENT WAS PARTIALLY DEPLOYED. THE WHITE TIP WAS BENT. DOCUMENT REVIEW PRIOR TO DISTRIBUTION ZIV6-125-14-8.0 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 RELEVANT MANUFACTURING RECORDS (C1721650) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS 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 C1721650. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0041-7). ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO RESISTANCE EXERTED ON THE DEVICE AS IT WAS ADVANCED ON THE WIRE GUIDE. SUMMARY THE 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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    DEVICE EVALUATED ON (B)(6) 2020: "RED SAFETY TAB STILL ATTACHED. STENT PARTIALLY DEPLOYED ON RETURN, APPROX. 0.5CM. WHITE TIP APPEARS TO BE BENT". PREVIOUSLY PROVIDED INFO: THE STENT WAS ADVANCED ALONG THE WIRE GUIDE (HPWAS-35-260)WITHOUT ANY RESISTANCE, BEFORE THE STENT ARRIVED TO THE SHEATH,THE DISTAL END OF THE STENT HAS BEEN DEPLOYED ABOUT 0.5CM , THE USER FOUND NO ABNORMAL AFTER CHECKED THE DELIVERY SYSTEM AND HANDLE , THE RED SAFE VALVE WAS GOOD . THEN THE USER REMOVED THE DEVICE AND REPLACED ANOTHER NEW STENT TO USE AND COMPLETED THE PROCEDURE SUCCESSFULLY. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    IT CAN BE NOTED THAT ZIV6-125-14-8.0 IS AN E.U. PART NUMBER - ONLY APPROVED IN THE US FOR ILIAC INDICATION ONLY. AS INDICATION IS NOT CONFIRMED FDA MDR ASSESSMENT REQUIRED. PMA/510(K) # OF SIMILAR DEVICE: P050017/S002 AND S003. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    THE STENT WAS ADVANCED ALONG THE WIRE GUIDE (HPWAS-35-260) WITHOUT ANY RESISTANCE, BEFORE THE STENT ARRIVED TO THE SHEATH,THE DISTAL END OF THE STENT HAS BEEN DEPLOYED ABOUT 0.5CM , THE USER FOUND NO ABNORMAL AFTER CHECKED THE DELIVERY SYSTEM AND HANDLE , THE RED SAFE VALVE WAS GOOD . THEN THE USER REMOVED THE DEVICE AND REPLACED ANOTHER NEW STENT TO USE AND COMPLETED THE PROCEDURE SUCCESSFULLY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749344 ZILVER 635 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK INC C1721650 10827002375533

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR