BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 11932299 · Received June 3, 2021

    Report

    Report Number
    3001845648-2021-00432
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    February 8, 2020
    Report Date
    November 18, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON NAME AND PRODUCT CODE - QAN PMA/510(K) # P200023. DEVICE EVALUATION: THE ZILVER VENA VENOUS SELF-EXPANDING STENT DEVICES OF UNKNOWN LOT NUMBERS INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENTS AND WERE NOT AVAILABLE FOR EVALUATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZILVER VENA VENOUS SELF-EXPANDING STENT (ZVT7) DEVICES 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. A REVIEW OF THE MANUFACTURING RECORDS FOR THESE ZILVER VENA VENOUS SELF-EXPANDING STENT DEVICES COULD NOT BE PERFORMED AS THE LOT NUMBERS ARE UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0047-5) ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT PRE-EXISTING CONDITIONS. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PARTICIPANTS IN THE STUDY HAD BEEN TREATED WITH VENOUS STENT PLACEMENT FOR EITHER ACUTE CAVO ILIOFEMORAL DVT OR CHRONIC DEEP VENOUS OBSTRUCTIONS. IT SHOULD ALSO BE NOTED THAT RESTENOSIS OR THROMBOSIS OF THE STENTED VEIN IS LISTED IN THE INSTRUCTIONS FOR USE (IFU0047-5) AS KNOWN POTENTIAL ADVERSE EVENT . SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE LITERATURE IN-STENT THROMBOSIS DEVELOPED IN 16 PATIENTS. FOUR PATIENTS WERE STENTED DURING THE ACUTE POST-THROMBOTIC PHASE AND 12 PATIENTS FOR CHRONIC POST-THROMBOTIC DEEP VENOUS OBSTRUCTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: P200023. SECTION D: COMMON NAME - QAN. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    NOTTEN ET AL 2020 ¿ QUALITY OF ANTICOAGULANT THERAPY AND THE INCIDENCE OF IN-STENT THROMBOSIS AFTER VENOUS STENTING. OBJECTIVES: TO DETERMINE THE ASSOCIATION BETWEEN THE QUALITY OF POSTINTERVENTIONAL VKA TREATMENT AND THE OCCURRENCE OF IN-STENT THROMBOSIS. PATIENTS WERE RECRUITED FROM A COHORT STUDY THAT WAS FOLLOWED AT THE MAASTRICHT UNIVERSITY MEDICAL CENTRE, THE NETHERLANDS, BETWEEN MARCH 2009 AND JANUARY 2013. SEVENTY-NINE OF THE 108 ELIGIBLE PATIENTS (73.1%) PROVIDED INFORMED CONSENT TO RETRIEVE ADDITIONAL DATA FROM THEIR INDIVIDUAL ANTICOAGULATION CLINIC AND COULD THEREFORE BE INCLUDED IN THIS STUDY. FORTY (50.6%) PATIENTS HAD A ¿LOW¿ TARGET INR (INR RANGE, 2.0-3.5) AND 39 (49.4%) PATIENTS HAD A ¿HIGH¿ TARGET INR (INR RANGE, 2.5-4.0). INDICATIONS FOR VENOUS STENT PLACEMENT WERE CLASSIFIED AS EITHER ACUTE CAVO-ILIOFEMORAL THROMBOSIS, OR CHRONIC DEEP VENOUS OBSTRUCTION DUE TO THE PRESENCE OF POSTTHROMBOTIC SEQUELAE (IE, PTS WITH POSTTHROMBOTIC SYNECHIAE), OR (NONTHROMBOTIC) ILIAC VEIN COMPRESSION SYNDROMES. PATIENTS WERE TREATED WITH PTA AND STENTING. STENTING IN THE ACUTE THROMBOTIC PHASE WAS USUALLY PERFORMED FOLLOWING TREATMENT WITH ULTRASOUND-ACCELERATED CDT. SELF-EXPANDABLE STENTS WITH DIAMETER SIZES RANGING FROM 12 TO 16 MM IN THE ILIOFEMORAL TRACT TO 24 MM IN THE CAVAL TRACT WERE USED IN ALL CASES: SINUS-XL, SINUS-XL FLEX, SINUS-VENOUS (OPTIMED), ZILVER VENA (COOK). TO RECONSTRUCT THE CONFLUENCE OF THE VENA CAVA IN THE LIMITED NUMBER OF PATIENTS WITH BILATERALLY AFFECTED ILIAC TRACTS, BALLOON EXPANDABLE STENTS SUCH AS THE ANDRASTENT (ANDRAMED) WERE USED. IN-STENT THROMBOSIS DEVELOPED IN 16 PATIENTS (20.3%) AFTER A MEDIAN OF 67.0(6.0-264.5) DAYS WITHIN A MEDIAN FOLLOW-UP OF 1200 (1037-1363) DAYS. 4 PATIENTS (25.0%) WERE STENTED DURING THE ACUTE POST THROMBOTIC PHASE. 12 (75.0%) PATIENTS WERE STENTED FOR CHRONIC POST-THROMBOTIC DEEP VENOUS OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832664 ZILVER VENA VENOUS SELF-EXPANDING STENT QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention