BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 518 VASCULAR SELF-EXPANDING STENT

    MDR report key: 10940268 · Received December 3, 2020

    Report

    Report Number
    3001845648-2020-00910
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Report Date
    August 20, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P050017/S002 AND S003. DEVICE EVALUATION: THE ZIV5-18-125-6-8 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZIV5-18-125-6-8 DEVICES ARE SUBJECT TO VISUAL 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 ZIV5-18-125-6-8 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE ARE IFU0043-9. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THERE IS NOT ENOUGH DETAILED INFORMATION AVAILABLE AT THE PRESENT TIME TO EVALUATE THE ROOT CAUSE FOR THE ZIV5-18-125-6-8 DEVICE BREAKAGE. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO COMPRESSION/STRESS ON THE STENT DUE TO TORTUROUS/DIFFICULT PATIENT ANATOMY. DIFFICULT ANATOMY CAN CAUSE EXCESSIVE PRESSURE ON THE STENT WHICH MAY CONTRIBUTE TO STENT FATIGUE/FRACTURES. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT IS NOT KNOWN IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THREE ATTEMPTS WERE MADE TO RETRIEVE ADDITIONAL INFORMATION FOR THIS COMPLAINT. NO PATIENT OUTCOME FOR THIS OCCURRENCE WAS AVAILABLE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: 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

    PER CUSTOMER (B)(6) 2020 - IT LOOKS LIKE A ZIV5-18-125-6-80 BROKE. PATIENT OUTCOME: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -NI. IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? -NI. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? -NI. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? -NI. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? -NI HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? -NI PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408133 ZILVER 518 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1