BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MECHANICAL HEART VALVE

    MDR report key: 14804421 · Received June 24, 2022

    Report

    Report Number
    2135147-2022-00426
    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
    OTHER

    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 3 MONTH OLD MALE INFANT WITH A HISTORY OF PERSISTENT TRUNCUS ARTERIOSUS. A 17MM SJM MECHANICAL HEART VALVE WAS IMPLANTED ON TRUNCAL VALVE. AFTER THE SURGERY, CARDIAC CATHETER TEST HAPPENED TO DETECT IMMOBILE ONE LEAFLET BY CHANCE. IT WAS CONSIDERED THAT THROMBI ADHERED ON THE LEAFLET. THE PATIENT WAS STARTED TO BE ADMINISTERED T-PA 0.03MG/KG/HR AND HEPARIN 20U/KG/HR. THE LEAFLET MOTION BECAME IMPROVED FOR 4-DAYS TREATMENT. 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
    770731 UNKNOWN MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Male Required Intervention