BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF EXPANDING STENT

    MDR report key: 16399256 · Received February 17, 2023

    Report

    Report Number
    3005580113-2023-00023
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    December 6, 2022
    Report Date
    February 17, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: QAN.

    Description of Event or Problem · 0

    HOFMANN 2022 - 12- MONTH ENDPOINT RESULTS FROM THE EVALUATION OF THE ZILVER VENA VENOUS STENT IN THE TREATMENT OF SYMPTOMATIC ILIOFEMORAL VENOUS OUTFLOW OBSTRUCTION (VIVO CLINICAL STUDY). TWO-VIEW VENOGRAPHY WAS PERFORMED TO ASSESS THE STUDY LESION CHARACTERISTICS (E.G., LOCATION, MINIMUM LUMEN DIAMETER [MLD]) AND TO ASSIST WITH STENT SIZING. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT CONSIDERED STANDARD OF CARE DURING STUDY DESIGN DEVELOPMENT AND WAS NOT REQUIRED PER THE PROTOCOL. MLD WAS DETERMINED USING TWO VENOGRAPHY PROJECTIONS, BASED ON DIAMETER MEASUREMENTS OF THE NARROWEST POINT IN THE TREATED SEGMENT OF VEIN (THE STENTED SEGMENT AND 1 CM ADDITIONAL CRANIAL AND CAUDAL TO THE STENT). VENOGRAPHIC MEASUREMENTS USED A CALIBRATION SOURCE (EITHER INTRAVASCULAR CALIBRATION DEVICE(S) OR AN EXTERNAL CALIBRATED DEVICE). PRE-DILATION OF THE VESSEL AND POST-STENT DILATATION WERE RECOMMENDED. STENTS WERE RECOMMENDED TO BE OVERSIZED BY 2-4 MM RELATIVE TO THE SURROUNDING VASCULATURE, THE EXPANDED BALLOON DIAMETER USED FOR PREDILATATION, OR THE STANDARD DIAMETER OF THE VEIN TO BE STENTED. STENTS WERE RECOMMENDED TO FULLY COVER THE LESION AND EXTEND INTO HEALTHY TISSUE (CAUDALLY AND CRANIALLY) BY 5-10 MM. WHEN MULTIPLE STENTS WERE REQUIRED, STENT OVERLAP BY AT LEAST 1 CM WAS RECOMMENDED. UPON PROCEDURE COMPLETION, TWO-VIEW VENOGRAPHY WAS USED TO EVALUATE THE LESION AND STENT PLACEMENT CHARACTERISTICS. TECHNICAL SUCCESS FAILURE: MAES AFTER 30 DAYS: INCLUDED 7 EVENTS OF CLINICALLY DRIVEN REINTERVENTIONS AND 1 EVENT OF NEW SYMPTOMATIC PE (PULMONARY EMBOLISM). MAES AFTER 12 MONTHS: SPECIFICALLY, 10 EVENTS OF CLINICALLY DRIVEN TARGET LESION REINTERVENTION, AND 2 EVENTS OF NEW SYMPTOMATIC PE. PER MEDICAL AFFAIRS INPUT: REQUIRE INTERVENTION/ADDITIONAL PROCEDURES. 243 PATIENTS. AVERAGE AGE: 53 YEARS. GENDER: FEMALE 170, MALE 73.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126348 ZILVER VENA VENOUS SELF EXPANDING STENT QAN COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention