BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 16860279 · Received May 3, 2023

    Report

    Report Number
    3001845648-2023-00318
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    March 11, 2022
    Report Date
    December 1, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA 510K#P050017 S002 AND S003. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    (B)(4). 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 WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. MANUFACTURING RECORDS REVIEW PRIOR TO DISTRIBUTION ALL ZILVER VENA DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND LABEL IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0091) LISTS ¿RESTENOSIS, OCCLUSION OR THROMBOSIS OF THE STENTED VEIN¿ AND "ABRUPT STENT CLOSURE" AS POTENTIAL ADVERSE EVENTS. 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 ANALYSIS A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE MECHANICAL FALL THAT THE PATIENT SUSTAINED 2 DAYS AFTER THE PROCEDURE. AS PER THE INFORMATION RECEIVED, IT IS KNOWN THAT THE PATIENT SUSTAINED A MECHANICAL FALL AND DEVELOPED THROMBOSIS WITHIN THE STENT AS A RESULT. OTHER POSSIBLE ROOT CAUSES INCLUDE THE PATIENT PRE-EXISTING CONDITIONS AND/OR KNOWN POTENTIAL COMPLICATIONS. AS PREVIOUSLY NOTED, ¿RESTENOSIS, OCCLUSION OR THROMBOSIS OF THE STENTED VEIN¿ AND "ABRUPT STENT CLOSURE" ARE LISTED AS POTENTIAL ADVERSE EVENTS IN THE IFU. CONFIRMATION OF COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AND/OR REP TESTIMONY. SUMMARY OF INVESTIGATION THE COMPLAINT WAS RAISED FROM LITERATURE PAPER ABAD-SANTOS ET AL ¿FLOWTRIEVER ASPIRATION THROMBECTOMY FOR THROMBOSED VENOUS STENTS: AN EXPERIENCE IN SEVEN PATIENTS¿. ACCORDING TO THE INITIAL REPORTER, A PATIENT UNDERWENT LEFT COMMON ILIAC AND LEFT EXTERNAL ILIAC VEIN STENT RECONSTRUCTION WITH 02 ZILVER VENA STENTS. THE PATIENT SUFFERED A MECHANICAL FALL AND WAS FOUND TO HAVE A LEFT ILIAC VEIN STENT THROMBOSIS. THE PATIENT REQUIRED THROMBECTOMY WITH BILATERAL ILIOCAVAL STENT RECONSTRUCTION AS A RESULT OF THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE POSSIBLE ROOT CAUSES INCLUDE THE MECHANICAL FALL THAT THE PATIENT SUSTAINED 2 DAYS AFTER THE PROCEDURE, THE PATIENT PRE-EXISTING CONDITIONS AND/OR KNOWN POTENTIAL COMPLICATIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ABAD-SANTOS, M., SHIN, D.S., MONROE, E.J., FLOWTRIEVER ASPIRATION THROMBECTOMY FOR THROMBOSED VENOUS STENTS: AN EXPERIENCE IN SEVEN PATIENTS. CARDIOVASC INTERVENT RADIOL (2022) 45:715¿717. THIS ARTICLE PRESENTS ON 13 THROMBOSED VENOUS GRAFTS IN 7 PATIENTS. 2 GRAFTS WERE REPORTED TO BE ZILVER VENA STENTS, IT IS UNCLEAR IF THESE STENTS ARE IN 1 PATIENT OR 2 PATIENTS. ONE PATIENT WITH A THROMBOSED ZILVER VENA STENT WAS A 47-YEAR-OLD WOMAN WHO SUFFERED A MECHANICAL FALL AND WAS FOUND 2 DAYS LATER TO HAVE A LEFT ILIAC VEIN STENT THROMBOSIS. THROMBECTOMY WAS PERFORMED WITH BILATERAL ILIOCAVAL STENT RECONSTRUCTION. COMPLETION VENOGRAPHY SHOWED FLOW THROUGH THE STENTS. THROMBECTOMY WAS PERFORMED WITH BILATERAL ILIOCAVAL STENT RECONSTRUCTION. COMPLETION VENOGRAPHY SHOWED FLOW THROUGH THE STENTS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543699 ZILVER VENA VENOUS SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention