BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 14589917 · Received June 3, 2022

    Report

    Report Number
    3001845648-2022-00343
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    April 30, 2021
    Report Date
    September 20, 2022
    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. COMMON NAME: (B)(6). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: P200023. SECTION D: COMMON NAME - QAN. DEVICE EVALUATION: THE UNKNOWN ZILVER VENA DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION ¿ N/A. 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 INSPECTIONS 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). ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED THE PATIENT¿S PRE-EXISTING CONDITION. BASED ON THE INCLUSION CRITERIA IN THE STUDY, IT IS KNOWN THAT THE PATIENT¿S PRE-EXISTING CONDITIONS INCLUDED PTS OR MTS, IPSILATERAL ILIOFEMORAL DVT AND OCCLUSION AT THE COMMON FEMORAL AND ILIAC VEINS WITH DISTAL PATENT COMMON FEMORAL VEIN AND ADEQUATE INFLOW. IT IS POSSIBLE THAT PATIENT PRE-EXISTING CONDITIONS CAUSED AND/OR CONTRIBUTED TO THE FORMATION OF OCCLUSION. AS MENTIONED ABOVE, OCCLUSION IS A KNOWN INHERENT RISK OF ENDOVASCULAR STENTING AND IS LISTED IN THE IFU AS A POTENTIAL ADVERSE EVENT. HOWEVER, THERE IS NO EVIDENCE WITHIN THE JOURNAL ARTICLE TO SUGGEST ANY DEVICE MALFUNCTION OR DETERIORATION IN DEVICE CHARACTERISTICS. THEREFORE, IT IS MORE LIKELY THAT PATIENT PRE-EXISTING CONDITION CAUSED OR CONTRIBUTED TO OCCLUSION FORMATION. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT(S) DID REQUIRE INTERVENTION/ADDITIONAL PROCEDURES TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SALEM ET AL 2021 - LONG-TERM OUTCOME OF DEDICATED VENOUS STENTS IN MANAGEMENT OF CHRONIC ILIOFEMORAL OBSTRUCTION. OBJECTIVE: TO STUDY THE LONG-TERM OUTCOMES IN PATIENTS WITH OCCLUSIVE ILIOFEMORAL CHRONIC VENOUS INSUFFICIENCY (CVI) OF BENIGN ETIOLOGY TREATED BY DEDICATED VENOUS STENTS (ZILVER VENA STENTS; COOK, (B)(6)) PLACED AT A SINGLE CENTER. WE PERFORMED RETROSPECTIVE ANALYSIS OF PROSPECTIVELY COLLECTED DATA FROM 58 PATIENTS WITH SYMPTOMATIC BENIGN LOWER LIMB CVI DURING THE PERIOD FROM JANUARY 2013 TO OCTOBER 2020. PATIENTS UNDERWENT RECANALIZATION USING ZILVER VENA STENTS AT (B)(6) HOSPITALS. WE EXCLUDED PATIENTS REQUIRING STENTING AFTER INTERVENTION FOR ACUTE DEEP VENOUS THROMBOSIS, CVI DUE TO MALIGNANCY OR VASCULAR MALFORMATIONS, PREVIOUS IPSILATERAL VENOUS INTERVENTIONS, OR CVI DUE TO NONOBSTRUCTIVE PATHOLOGY (REFLUX). PATIENTS WERE CLINICALLY CLASSIFIED AT ENROLLMENT BY THE CLINICAL, ETIOLOGY, ANATOMY, PATHOLOGY CLASS, VENOUS DISABILITY SCORE, AND VILLALTA SCORE. PRIMARY, ASSISTED PRIMARY, AND SECONDARY STENT PATENCY WERE ASSESSED. PATIENTS WERE FOLLOWED CLINICALLY AND BY DUPLEX, AT 1, 3, 6, 12 MONTHS AND ANNUALLY FOR 5 YEARS. THIS COMPLAINT WAS OPENED TO CAPTURE STENT OCCLUSION - 10 PATIENTS IN TOTAL. IN 2013, 1 PATIENT PRESENTED AT 4 YEARS WITH AN OCCLUDED STENT WITH FAILED RECANALIZATION. IN 2014, 1 PATIENT PRESENTED AFTER 1 YEAR WITH OCCLUDED CIV AND EIV STENTS BUT REFUSED REINTERVENTION. AT END OF STUDY, 7 PATIENTS PRESENTED WITH OCCLUDED STENTS AND FAILED RECANALIZATION. AFTER 3 YEARS, 1 PATIENT NEEDED RECANALIZATION AND WAS PATENT TILL THE END OF THE STUDY (7 YEARS¿ SECONDARY PATENCY). REQUIRE INTERVENTION/ADDITIONAL PROCEDURES TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586183 ZILVER VENA VENOUS SELF-EXPANDING STENT Stent, iliac vein QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention