BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALN OPTIONAL VENA CAVA FILTER

    MDR report key: 19738299 · Received July 15, 2024

    Report

    Report Number
    3007080617-2024-00001
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    October 31, 2023
    Report Date
    July 15, 2024
    Manufacturer
    ALN S.A.R.L.
    Product Code
    DTK
    UDI-DI
    03760017680011
    PMA / PMN Number
    K163699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT THE IVC FILTER PLACEMENT ABOUT 1.5 YEARS AGO (APPROXIMATE IMPLANTATION DATE: (B)(6) 2022). THE ATTENDING PHYSICIAN THIS TIME OBSERVED UNDER COMPUTED TOMOGRAPHY AT THE PATIENT'S 1.5-YEAR FOLLOW-UP VISIT THAT THE INFERIOR VENA CAVA WAS PERFORATED. TO BE MORE SPECIFIC, THE PHYSICIAN OBSERVED THE PERFORATION BY AND DEVIATION OF 6 LEGS OF THE FILTER. DAMAGES TO THE AORTA WERE ALSO DEEPLY CONCERNED. THE PHYSICIAN REMOVED THE FILTER SURGICALLY. THE REMOVED FILTER WAS DISPOSED OF BY THE MEDICAL INSTITUTION. PATIENT'S CONDITION AFTER THE OPERATION: FAVORABLE. THIS INFORMATION WAS OBTAINED THROUGH A POSTER PRESENTATION AT THE JAPANESE SOCIETY FOR VASCULAR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210981 ALN OPTIONAL VENA CAVA FILTER VENA CAVA FILTER DTK ALN S.A.R.L. FJ.120096 03760017680011

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention