BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 11640027 · Received April 9, 2021

    Report

    Report Number
    3001845648-2021-00292
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    October 16, 2020
    Report Date
    October 29, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P200023 PRODUCT CODE: QAN DEVICE EVALUATION THE ZILVER VENA VENOUS SELF EXPANDING STENT (ZVT-7) DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENTS AND WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. 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 ZILVER VENA VENOUS SELF EXPANDING STENT 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 IFU (IFU0047-5). A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE RELATED TO PATIENTS PRE-EXISTING CONDITIONS. IT IS KNOWN THAT THAT THE PATIENTS INCLUDED IN THE STUDY HAS SUFFERED WITH EITHER ACUTE OR CHRONIC DEEP VEIN THROMBOSIS OR HAS BEEN TREATED FOR POST THROMBOTIC SYNDROME OR ILIAC VENOUS COMPRESSION SYNDROMES. IT SHOULD BE NOTED THAT RESTENOSIS IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE INSTRUCTIONS FOR USE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORT ALL PATIENTS WERE TREATED SUCCESSFULLY WITH THROMBOLYSIS, BALLOON ANGIOPLASTY, OR STENTING COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    FINAL MDR BEING SUBMITTED FUE TO COMPLETION OF THE INVESTIGATION ON 29-OCT-21

    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 AND 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 PATENCY RATE WAS 90% (27/30), AND THREE CASES OF REOCCLUSION OCCURRED. ONE WAS DETECTED IN THE SECOND MONTH WITH THROMBOSIS IN THE STENT. THE OTHER TWO CASES WERE DETECTED IN MONTHS 6 AND 8 AS A RESULT OF STENOSIS OF THE STENTED SECTIONS. ALL WERE TREATED SUCCESSFULLY WITH THROMBOLYSIS, BALLOON ANGIOPLASTY, OR STENTING. THIS COMPLAINT WILL CAPTURE 2 CASES OF RESTENOSIS IN MONTHS 6 AND 8 AS A RESULT OF STENOSIS OF THE STENTED SECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537697 ZILVER VENA VENOUS SELF EXPANDING STENT QAN COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown Required Intervention