BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 11640247 · Received April 9, 2021

    Report

    Report Number
    3001845648-2021-00288
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    October 16, 2020
    Report Date
    January 21, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P200023. COMMON NAME: QAN, PRODUCT CODE: QAN. DEVICE EVALUATION THE UNKNOWN ZVT7 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZVT7 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. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IFU0047-5. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENTS PRE-EXISTING CONDITION, MAY THURNERS SYNDROME, WHICH MAY HAVE PUT EXCESSIVE PRESSURE ON THE STENT, RESULTING IN STENT KINKING. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS REQUIRED SURGICAL INTERVENTION DUE TO THE THROMBOSIS CAUSED BY STENT KINKING. 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.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P200023. PRODUCT CODE: QAN. (B)(4). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    FU 2020, ZILVER VENA, STENT CHARACTERISTICS OF 32 PATIENTS WITH EARLY (<14 DAYS) ILIOFEMORAL STENT OCCLUSION. PATIENTS DIAGNOSED WITH EARLY IN-STENT THROMBOSIS AFTER ILIOFEMORAL STENTING WERE REVIEWED IN THIS RETROSPECTIVE ANALYSIS. PATIENTS WITH A RECURRENCE OF SYMPTOMS OR THE DETECTION OF THROMBUS IN STENTS WITHIN 14 DAYS AFTER STENT IMPLANTATION WERE INCLUDED. PATIENTS WITH STENTS PLACED BELOW THE ORIFICE OF THE DEEP FEMORAL VEIN WERE EXCLUDED. THE SECOND FACTOR WAS STENT-RELATED FAILURE: A THROMBUS FORMED IN FOUR PATIENTS BECAUSE OF STENT KINKING AND COMPRESSION. 4 STENTS WERE PLACED IN THESE NINE PATIENTS AFTER SUCCESSFUL THROMBOLYSIS. THIS COMPLAINT IS CAPTURING 4 CASES OF STENT KINKING REQUIRING THROMBOLYSIS AND POTENTIAL RE-STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538309 ZILVER VENA VENOUS SELF EXPANDING STENT QAN COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown Required Intervention