BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 19113833 · Received April 16, 2024

    Report

    Report Number
    3001845648-2024-00178
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    February 7, 2024
    Report Date
    November 19, 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 16 CASES OF LOSS OF PATENCY REQUIRING INTERVENTION 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 MAY BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0091) LISTS RESTENOSIS, OCCLUSION OR THROMBOSIS OF THE STENTED VEIN AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE FOR LOSS OF PATENCY COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. PRE-EXISTING CONDITIONS INCLUDED RISK FACTORS FOR THROMBOSIS OR OCCLUSION INCLUDING BLEEDING DIATHESIS OR COAGULOPATHY, HYPERTENSION, DVT, PRESENCE OF REFLUX, AND CLOTTING DISORDER. IT IS ALSO KNOWN THAT 41 OF THE 243 PATENTS HAD A HISTORY OF CANCER. IT IS POSSIBLE THAT TUMOUR INGROWTH/OVERGROWTH COULD HAVE CONTRIBUTED TO THE LOSS OF PATENCY. AS PREVIOUSLY MENTIONED, THE IFU LISTS RESTENOSIS, OCCLUSION OR THROMBOSIS OF THE STENTED VEIN AS A POTENTIAL ADVERSE EVENT. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY: ACCORDING TO THE INITIAL REPORTER, 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 FILE CAPTURES LOSS OF PATENCY REQUIRING INTERVENTION IN THE US, 16 CLINICALLY DRIVEN REINTERVENTIONS (12 FROM PTS PATIENTS AND 4 FROM DVT PATIENTS). CONFIRMED QUANTITY OF 16 DEVICES, CONFIRMED USED. AS PER MEDICAL ADVISOR INPUT, PATIENT OUTCOME WOULD "REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4." INVESTIGATION FINDINGS CONCLUDE THAT A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING/BASELINE CHARACTERISTICS. AS PREVIOUSLY NOTED, RESTENOSIS OF THE STENTED ARTERY AND OCCLUSION ARE KNOWN POTENTIAL ADVERSE EVENTS.

    Description of Event or Problem · 0

    CONCERTA, 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 REINTER VENTION, 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. LOSS OF PATENCY: THE KM ESTIMATES FOR PATENCY BY ULTRASOUND AT 1095 DAYS WAS 90.3% FOR THE BLIND-ALL GROUP (TABLE 3). SIMILARLY, PATENCY RATES BY ULTRASOUND WERE 100%, 84.0%, AND 86.1% FOR THE NIVL, ADVT, AND PTS PATIENTS, RESPECTIVELY. 9.7% HAD A LOSS OF PATENCY. THE KM ESTIMATES FOR FREEDOM FROM CLINICALLY DRIVEN REINTERVENTION 92.1% AT 1095 DAYS FOR ADVT PATIENTS, 87.1% AT 1095 DAYS FOR PTS PATIENTS, 1095 DAYS FOR NIVL PATIENTS . 7.9% OF ADVT AND 12.9% OF PTS REQUIRED INTERVENTION 16 CLINICALLY DRIVEN REINTERVENTIONS (12 FROM PTS PATIENTS AND 4 FROM ADVT PATIENTS) PATIENT OUTCOME: REQUIRE INTERVENTION/ADDITIONAL PROCEDURES S=4 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 COMPLETION OF THE INVESTIGATION ON 19-NOV-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445789 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