BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 12504408 · Received September 21, 2021

    Report

    Report Number
    3001845648-2021-00682
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 24, 2021
    Report Date
    October 14, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    UDI-DI
    10827002574486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON NAME: QAN. PMA/510(K) #: P200023. DEVICE EVALUATION: THE ZVT7-35-80-16-100 DEVICE OF LOT NUMBER C1798360 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) 2021. ON EVALUATION OF THE DEVICE, A SEVERE BREAK WAS NOTED ON THE DISTAL WHITE TIP. THE DEVICE FLUSHED AS EXPECTED. A 0.035 INCH WIRE GUIDE PASSED THROUGH THE DEVICE WITHOUT ISSUES. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZVT7-35-80-16-100 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 ZVT7-35-80-16-100 OF LOT NUMBER C1798360 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 C1798360. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE ARE IFU0091-7. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW ¿ N/A. 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 POSSIBLE IMPACT DURING TRANSPORTATION. IT IS POSSIBLE THAT THE DEVICE MAY HAVE BEEN SUBJECTED TO IMPACT DURING TRANSPORTATION WHICH LED TO CRACKS/BREAKS ON THE DELIVERY SYSTEM. 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 DID NOT MAKE PATIENT CONTACT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE (B)(6) AND THE DEVICE EVALUATION ON THE (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P200023. PRODUCT CODE: QAN. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    THE TIP SEEMED TO BE BROKEN. OBSERVED THAT WHEN THEY OPENED HTE PACKAGE AND REMOVED THE DEVICE TO PLACE ON THE TABLE. CUSTOMER BELIEVES IT WAS LIKE THIS WHEN THEY OPENED THE PACKAGE. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? N/A NOT USED. IF YES, PLEASE DESCRIBE. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? N/A NOT USED. IF YES, PLEASE DESCRIBE. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? N/A NOT USED. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? N/A NOT USED. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? N/A NOT USED. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408189 ZILVER VENA VENOUS SELF-EXPANDING STENT QAN COOK IRELAND LTD G57448 C1798360 10827002574486

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown