BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALN OPTIONAL VENA CAVA FILTER WITH HOOK

    MDR report key: 23810905 · Received December 15, 2025

    Report

    Report Number
    MW5180556
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 10, 2025
    Manufacturer
    ALN S.A.R.L.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT WAS HAVING AN IVC FILTER PLACED WHEN THE DEVICE PUNCTURED THROUGH THE SHEATH PRIOR TO FULL INSERTION INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661831 ALN OPTIONAL VENA CAVA FILTER WITH HOOK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK ALN S.A.R.L. 060225

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male