BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALN OPTIONAL VENA CAVA FILTER

    MDR report key: 22529990 · Received July 17, 2025

    Report

    Report Number
    3007080617-2025-00001
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 5, 2025
    Report Date
    August 14, 2025
    Manufacturer
    ALN S.A.R.L
    Product Code
    DTK
    UDI-DI
    03760017680042
    PMA / PMN Number
    K241507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE REQUIRE ADDITIONAL INFORMATION TO UNDERSTAND HOW THE LEGS COULD HAVE FRACTURED AT THAT SPECIFIC LOCATION, PARTICULARLY REGARDING THE RETRIEVAL PROCEDURE, WHETHER IT WAS PERFORMED USING AN ALN REMOVAL KIT OR A SNARE. WE ALSO NEED THE FULL CAVOGRAPHY SEQUENCE IN ORDER TO ASSESS THE ENTIRE EXTRACTION PROCESS, TOGETHER WITH PRE-OPERATIVE AND POST-OPERATIVE SCANS TO COMPLETE OUR INVESTIGATION.

    Description of Event or Problem · 0

    THE FILTER WAS PLACED ON THE (B)(6) 2024 AND REMOVED ON (B)(6) 2025.LASSO TECHNIQUE WAS USED FOR THE FILTER REMOVAL (COOK CLOVERSNARE®).

    Description of Event or Problem · 0

    DURING THE RETRIEVAL PROCEDURE OF THE VENA CAVA FILTER, A SMALL FRAGMENT OF ONE OF THE FILTER'S LEGS FRACTURED AND REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT IS CURRENTLY ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672376 ALN OPTIONAL VENA CAVA FILTER VENA CAVA FILTER DTK ALN S.A.R.L FF.HOOK 2400177234 03760017680042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other