BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 14575174 · Received June 2, 2022

    Report

    Report Number
    3001845648-2022-00340
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    August 24, 2020
    Report Date
    November 22, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. ZILVER VENA PRODUCT CODE: QAN. 510 K # P200023.

    Additional Manufacturer Narrative · 0

    ZILVER VENA PRODUCT CODE: QAN. 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 PR (B)(4) AND IT WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. DOCUMENT 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 WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0047) LISTS RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN AS A POTENTIAL ADVERSE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. FROM THE AVAILABLE INFORMATION IT IS KNOWN THAT ALL PATIENTS IN THE STUDY SUFFERED FROM POST-THROMBOTIC SYNDROME. RISK FACTORS INCLUDED VARICOSE VEINS, OBESITY, KNOWN THROMBOPHILIA, HISTORY OF PULMONARY EMBOLISM, DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE. IT IS POSSIBLE THAT THE PATIENTS PRE-EXISTING CONDITIONS CAUSED AND/OR CONTRIBUTED TO THE EVENTS OF IN STENT STENOSIS AND STENT OCCLUSION. IT SHOULD ALSO BE NOTED THAT THE IFU LISTS RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN AS A KNOWN POTENTIAL ADVERSE EVENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE COMPLAINT WAS RAISED FROM LITERATURE PAPER MOERI ET AL ¿BRAIDED OR LASER-CUT SELF-EXPANDING NITINOL STENTS FOR THE COMMON FEMORAL VEIN IN PATIENTS WITH POST-THROMBOTIC SYNDROME¿. THE PAPER REPORTED 27 CASES OF STENT OCCLUSION AND 9 CASES OF IN-STENT STENOSIS. REINTERVENTION WAS REQUIRED AS A RESULT OF IN STENT STENOSIS OR STENT OCCLUSION IN POTENTIALLY 10 CASES DUE TO THE PLACEMENT OF 10 ZILVER STENTS IN THE STUDY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    MOERI, 2020, ZILVER VENA - "BRAIDED OR LASER-CUT SELF-EXPANDING NITINOL STENTS FOR THE COMMON FEMORAL VEIN IN PATIENTS WITH POST-THROMBOTIC SYNDROME". VENOUS ACCESS WAS OBTAINED IN THE FEMOROPOPLITEAL SEGMENT OR INTERNAL JUGULAR VEIN. THE DECISION TO IMPLANT STENTS WAS DETERMINED BY THE PRESENCE OF VENOUS OBSTRUCTION. IMPLANTATION OF COMMON FEMORAL VEIN STENTS REQUIRED PREDILATATION WITH 12- OR 14-MM HIGH-PRESSURE BALLOON CATHETERS TO ACHIEVE A NOMINAL DIAMETER FOR IMPLANTATION OF 12- OR 14-MM STENTS. ALL BRAIDED AND LASER-CUT STENTS WERE POSTDILATED USING 12- OR 14-MM HIGH-PRESSURE BALLOON CATHETERS. THE PROXIMAL STENT LANDING ZONE WAS THE INFERIOR VENA CAVA IN 32 PATIENTS (21%), THE ILIAC VEIN IN 106 PATIENTS (76%), AND THE COMMON FEMORAL VEIN IN 5 PATIENTS (3%). 4 PATIENTS EXPERIENCED IN STENT STENOSIS OR STENT OCCLUSION, DETAILS BELOW: PATIENT 2 - SYMPTOMATIC IN-STENT STENOSIS OF EXTERNAL ILIAC VEIN AND COMMON FEMORAL VEIN. INTERVENTION - PTA; STENT-IN-STENT (WITH SINUS-XL FLEX). PATIENT 10 - IN-STENT STENOSIS OF COMMON ILIAC AND EXTERNAL ILIAC VEINS. INTERVENTION - PTA OF COMMON ILIAC AND EXTERNAL ILIAC VEINS; STENT-IN-STENT OF COMMON ILIAC AND EXTERNAL ILIAC VEINS (WITH SINUS-XL FLEX). PATIENT 12 - IN-STENT STENOSIS OF EXTERNAL ILIAC AND COMMON ILIAC VEIN. INTERVENTION - PTA OF EXTERNAL ILIAC AND COMMON FEMORAL VEINS; STENT-IN-STENT OF EXTERNAL ILIAC AND COMMON FEMORAL VEINS (WITH BLUEFLOW). PATIENT 15 - STENT OCCLUSION OF INFERIOR VENA CAVA. INTERVENTION ¿ NO DETAILS. INTERVENTION ADDITIONAL STENT PLACED AND PTA.

    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
    2413688 ZILVER VENA VENOUS SELF EXPANDING STENT Stent, iliac vein QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention