BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 11658404 · Received April 13, 2021

    Report

    Report Number
    3001845648-2021-00304
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    February 17, 2020
    Report Date
    July 30, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: QAN. 510(K): P200023. DEVICE EVALUATION: THE TWO ZILVER VENA VENOUS SELF EXPANDING STENTS (ZVT7) OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENTS AND NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: AS THE LOT NUMBERS OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZILVER VENA VENOUS SELF EXPANDING STENTS ARE SUBJECTED TO 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 EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE ((B)(4)). THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: INTENDED USE: THE ZILVER VENA VENOUS STENT IS INTENDED FOR USE IN THE ILIOFEMORAL VEINS FOR THE TREATMENT OF SYMPTOMATIC VENOUS OUTFLOW OBSTRUCTION. ACCORDING TO THE LITERATURE THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT WITH RENAL VEIN STENT PLACEMENT. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. ACCORDING TO THE LITERATURE THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT WITH RENAL VEIN STENT PLACEMENT. THE ZILVER VENA VENOUS STENT IS INTENDED FOR USE IN THE ILIOFEMORAL VEINS. IT IS NOT POSSIBLE TO STATE HOW THE DEVICE WILL PERFORM WHEN USED OUTSIDE OF ITS VALIDATED STATE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE LITERATURE THE PATIENT UNDERWENT A SECOND PROCEDURE; HOWEVER, IMPROVEMENT WAS TEMPORARY, AND HER PAIN RETURNED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AMATO, 2020, ZILVER VENA: 'COMBINED NUTCRACKER AND EHLERS-DANLOS SYNDROMES: A CASE REPORT' A (B)(6) YEAR-OLD WOMAN PRESENTED WITH LOW BACK AND PELVIC PAIN. FOLLOWING THE DIAGNOSIS OF NUTCRACKER SYNDROME, SHE UNDERWENT ENDOVASCULAR TREATMENT WITH RENAL VEIN STENT PLACEMENT; HOWEVER, THE PATIENT CONTINUED TO COMPLAIN OF PAIN. FURTHER EXAMINATIONS REVEALED LEFT RENAL VEIN COMPRESSION BY THE PORTAL VEIN. THE PATIENT UNDERWENT A SECOND PROCEDURE; HOWEVER, IMPROVEMENT WAS TEMPORARY, AND HER PAIN RETURNED. FURTHER INVESTIGATION REVEALED PREVIOUSLY UNDETECTED NEPHROPTOSIS AND HYPERELASTICITY. A DIAGNOSIS OF EHLERSEDANLOS SYNDROME MADE, POSSIBLY EXPLAINING THE MOBILITY OF VISCERA AND UNUSUAL COMPRESSION OF THE LEFT RENAL VEIN BY THE PORTAL VEIN. (B)(4) IS CAPTURING OFF-LABEL USE OF THE ZILVER VENA DUE TO PLACEMENT IN THE LEFT RENAL VEIN.

    Description of Event or Problem · 0

    FINAL MDR REPORT BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 30-JUL-21.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558170 ZILVER VENA VENOUS SELF EXPANDING STENT QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention