BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MECHANICAL HEART VALVE

    MDR report key: 14804571 · Received June 24, 2022

    Report

    Report Number
    2135147-2022-00427
    Event Type
    Injury
    Date Received
    June 24, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF THROMBUS ON A MECHANICAL VALVE LEAFLET WHICH WAS RESTRICTING THE LEAFLETS MOTION WAS REPORTED THROUGH A RESEARCH ARTICLE. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR ADDITIONAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT OF COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    AN ARTICLE FROM THE JAPANESE SOCIETY OF INTENSIVE CARE MEDICINE WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE OF A ONE YEAR AND 10 MONTH OLD FEMALE INFANT. NORWOOD PROCEDURE WAS PERFORMED FOR DOUBLE-OUTLET RIGHT VENTRICLE (DORV). A 17MM SJM MECHANICAL HEART VALVE WAS IMPLANTED IN AN AORTIC POSITION DUE TO AORTIC REGURGITATION AFTER NORWOOD PROCEDURE. A LEAFLET CLICK SOUND BECAME INAUDIBLE TWO MONTH AFTER AORTIC VALVE REPLACEMENT (AVR). IT WAS DIAGNOSED THAT THROMBI ADHERED ONTO THE LEAFLET WHICH INTERFERED LEAFLET MOTION. THE PATIENT WAS ADMINISTERED T-PA 0.045MG/KG/HR. AND HEPARIN 9.3U/KG/HR. T-PA WAS INCREASED UP TO 0.063MG/KG/HR. AS MAXIMUM ADMINISTRATION. 6DAYS ADMINISTRATION IMPROVED THE LEAFLET MOTION. MILD SUBCUTANEOUS HEMATOMA WAS OBSERVED AS SIDE-EFFECT. HEMODYNAMIC STATUS WAS STABLE THROUGHOUT THIS EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE. [ THE AUTHOR AND CORRESPONDING AUTHOR OF THIS ARTICLE IS HAYASHI, KEN, MD, KOBE CITY MEDICAL CENTER GENERAL HOSPITAL JAPAN, 650-0047 HYOGO, KOBE, CHUO WARD, MINATOJIMA MINAMIMACHI, 2 CHOME-1-1 TEL: +011(081)783024321 ].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890054 UNKNOWN MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Female Required Intervention