BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MECHANICAL HEART VALVE

    MDR report key: 15652530 · Received October 21, 2022

    Report

    Report Number
    2135147-2022-01729
    Event Type
    Injury
    Date Received
    October 21, 2022
    Report Date
    January 9, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF RIGHT PULMONARY EFFUSION AND ONE OF THE LEAFLETS BEING IMMOBILIZED WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT, INCLUDING HISTOPATHOLOGICAL EXAMINATION OF THE VALVE COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. D4: THE UDI NUMBER IS NOT KNOWN AS THE LOT AND SERIAL NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    AN ARTICLE FROM THE EXAMINATION AND TECHNOLOGY (JPN), 50(9): 2022, 972-973. ISSN; 0301-2611; REPORT A CASE OF A 29MM UNKNOWN SJM MECHANICAL HEART VALVE WHICH WAS IMPLANTED IN A MITRAL POSITION ON UNKNOWN DATE AND YEAR. ON UNKNOWN DATE AND YEAR, AN ECHOCARDIOGRAPHY PERFORMED, AND THE FOLLOWING FINDINGS WERE DETECTED. IVS 10 MM, PWT 9 MM, LVDD 42 MM, LVDS 23 MM, FS 45%, EF 76% LAD 51 MM, AOD 33 MM, AORTIC ROOT 27 MM. LV MASS 145 G, INDEX 88 G/M2, RVSP 45 MMHG, ONE LEAFLET HAD BECOME IMMOBILIZED. THE OTHER LEAFLET WHICH HAD BEEN IN MOTION, HAD ALSO OPENED INCOMPLETELY. THEREFORE, THE ANNULUS WAS SEVERELY STENOSED. THE MATERIAL ADHERING ONTO THE LEAFLETS WAS NOT ABLE TO BE IDENTIFIED THOUGH, THROMBUS WAS SUSPECTED. ALTHOUGH THE LEFT VENTRICULAR FUNCTION WAS WITHIN NORMAL, RIGHT VENTRICLE PRESSURE WAS BEING INCREASED AND RIGHT PULMONARY EFFUSION WAS CONFIRMED. THERE IS NO FURTHER INFORMATION AVAILABLE WHETHER ANY TREATMENT WAS PERFORMED TO THIS PATIENT. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR OF THIS ARTICLE IS TADASHI, TANEMURA, MD, 3-CHOME-2-19 NISHIAZABU MINATO CITY, TOKYO 106-0031 JAPAN].

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648218 UNKNOWN MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other