BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 20608022 · Received November 5, 2024

    Report

    Report Number
    3001845648-2024-00641
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    September 29, 2024
    Report Date
    July 29, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002518831
    PMA / PMN Number
    P050017/S006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: P050017/S006. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    OFF LABEL USE OF SINUS STENTING WITH ADDITIONAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72183 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD G51883 C2041039 10827002518831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown