BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 19113859 · Received April 16, 2024

    Report

    Report Number
    3001845648-2024-00179
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    February 7, 2024
    Report Date
    September 4, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: P200023. DEVICE EVALUATION THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE IS RELATED TO (B)(4) AND WAS CREATED FROM THE JOURNAL ARTICLE COMEROTA ET AL 2024 ¿FINAL 3-YEAR STUDY OUTCOMES FROM THE EVALUATION OF THE ZILVER VENA VENOUS STENT FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION (VIVO CLINICAL STUDY)¿ THIS COMPLAINT CAPTURES 09 CASES OF PULMONARY EMBOLISM IN THE US, (B)(4) CAPTURES THE POSSIBILITY THAT THE EVENT OCCURRED IN TAIWAN. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE/LABEL: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0091) LISTS PULMONARY EMBOLISM AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU OR LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED HOWEVER A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. FROM THE ARTICLE IT IS KNOWN THAT PATIENT PRE-EXISTING CONDITIONS INCLUDED RISK FACTORS FOR PULMONARY EMBOLISM INCLUDING CORONARY ARTERY DISEASE AND CLOTTING DISORDER. IT SHOULD ALSO BE NOTED THAT PULMONARY EMBOLISM IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CONFIRMED QUANTITY OF (B)(4) USED DEVICES. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY: THIS FILE WAS CREATED FROM JOURNAL ARTICLE COMEROTA, 2024 ¿ FINAL 3-YEAR STUDY OUTCOMES FROM THE EVALUATION OF THE ZILVER VENA VENOUS STENT FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION (VIVO CLINICAL STUDY)¿. THIS COMPLAINT CAPTURES 09 CASES OF PULMONARY EMBOLISM IN THE US. ACCORDING TO THE PAPER, NEW PULMONARY EMBOLISM WAS REPORTED IN 09 PATIENTS, THE TREATMENT WAS NOT REPORTED IN THE ARTICLE HOWEVER IT IS LIKELY THAT THIS WOULD HAVE RESULTED IN AN INTERVENTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    COMEROTA, 2024 ¿ FINAL 3-YEAR STUDY OUTCOMES FROM THE EVALUATION OF THE ZILVER VENA VENOUS STENT FOR THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION (VIVO CLINICAL STUDY). THE BLIND STUDY INCLUDED PATIENTS WITH SYMPTOMATIC OBSTRUCTION OF ONE ILIOFEMORAL VENOUS SEGMENT (I.E., ONE LIMB), CHARACTERIZED BY A CEAP CLINICAL CLASSIFICATION OF = 3 OR A VCSS PAIN SCORE = 2. PATIENTS WERE RETROSPECTIVELY GROUPED, BASED ON BASELINE CLINICAL PRESENTATION, AS: POST-THROMBOTIC (PTS), NON-THROMBOTIC (NIVL), OR ACUTE DVT (ADVT). CLINICAL IMPROVEMENT WAS ASSESSED BY CHANGE IN VCSS, VDS, CIVIQ-20 SCORES, AND CEAP ¿C¿ CLASSIFICATION. STENT PERFORMANCE WAS EVALUATED BY RATES OF PATENCY BY ULTRASOUND, FREEDOM FROM CLINICALLY DRIVEN REINTERVENTION, AND FREEDOM FROM STENT FRACTURE. THIS STUDY WAS A PROSPECTIVE, NON-RANDOMIZED, SINGLE-ARM, MULTICENTER TRIAL CONDUCTED UNDER AN IDE STUDY 29 SITES IN THE UNITED STATES AND ONE SITE IN TAIWAN. THIS FILE WILL CONSERVATIVELY CAPTURE ALL EVENTS OCCURRING IN THE US. 9 NEW SYMPTOMATIC PE (6 FROM PTS PATIENTS AND 3 FROM ADVT PATIENTS) PATIENT OUTCOME: NOT PROVIDED. PATIENT/EVENT INFO - NOTES: 188 PATIENTS TOTAL 43% PTS GROUP ~ 81, 33% NIVL GROUP ~ 62, 24% ADVT GROUP ~45. AVERAGE AGE 53. AGE RANGE 18-89. 70% FEMALE PATIENTS.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 04-SEP-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125705 ZILVER VENA VENOUS SELF EXPANDING STENT STENT, ILIAC VEIN QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention