BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALN OPTIONAL VENA CAVA FILTER

    MDR report key: 16434056 · Received February 24, 2023

    Report

    Report Number
    3007080617-2023-00001
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    December 17, 2022
    Report Date
    February 23, 2023
    Manufacturer
    ALN S.A.R.L.
    Product Code
    DTK
    UDI-DI
    03760017680042
    PMA / PMN Number
    K163699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    UPON DEPLOYMENT OF IVC FILTER, MIGRATED TO THE LEVEL OF THE PULMONARY ARTERY. THE PHYSICIAN WAS ABLE TO SNARE AND REMOVE THE FILTER IN ITS ENTIRETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023665 ALN OPTIONAL VENA CAVA FILTER VENA CAVA FILTER DTK ALN S.A.R.L. FF.HOOK 020721 03760017680042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening