BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALN OPTIONAL VENA CAVA FILTER

    MDR report key: 8603532 · Received May 13, 2019

    Report

    Report Number
    3007080617-2019-00002
    Event Type
    Injury
    Date Received
    May 13, 2019
    Report Date
    April 9, 2019
    Manufacturer
    A.L.N.
    Product Code
    DTK
    PMA / PMN Number
    K163699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE SEVERAL ATTEMPTS WITH THE PHYSICIAN, IT WAS NOT POSSIBLE TO HAVE MORE INFORMATION. THE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. THIS CASE OF MIGRATION IN PULMONARY ARTERY IS AN ISOLATED EVENT WITHOUT ANY CLINICAL COMPLICATIONS AND WITHOUT ANY SYMPTOM FOR THE PATIENT.

    Description of Event or Problem · 1

    IN (B)(6) 2018, DR (B)(6) FROM (B)(6) HOSPITAL AT (B)(6) HAS IMPLANTED A VENA CAVA FILTER BY RIGHT FEMORAL APPROACH (BECAUSE THE PATIENT HAD A PACEMAKER) FOR A PULMONARY EMBOLISM WITH DEEP VEIN THROMBOSIS AND INTRA-CEREBRAL HAEMORRHAGES. THE PHYSICIAN HAS MEASURED THE VENA CAVA DIAMETER WHICH WAS 27 MM. HE SAYS HE HAS CHECKED THE POSITION OF RENAL VEINS ON PREVIOUS EXAMINATIONS. FURTHER TO A RECENT CHEST SCANNER DONE BY RADIOLOGISTS, THEY HAVE DISCOVERED THE VENA CAVA FILTER IN THE RIGHT PULMONARY ARTERY. TO DATE, THE ASYMPTOMATIC PATIENT WAS ONLY SEEN TO OUTPATIENT CARE AND WENT HOME; KNOWING THAT HE HAS BEEN ADMINISTERED ANTICOAGULANTS AT LONG-TERM. DR. (B)(6) HAS TRANSMITTED TO THE PROFESSOR (B)(6) (EXPERT IN CAVA FILTRATION) THE IMPLANTATION REPORTS AND THE IMAGES OF THE CAVOGRAPHY BEFORE AND AFTER IMPLANTATION. THEY ARE IN TOUCH TO DISCUSS ABOUT THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396719 ALN OPTIONAL VENA CAVA FILTER VENA CAVA FILTER DTK A.L.N. FF.010995 180717

    Patients

    Seq Age Sex Outcome Treatment
    1 Other