BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MECHANICAL HEART VALVE

    MDR report key: 10814769 · Received November 10, 2020

    Report

    Report Number
    2648612-2020-00117
    Event Type
    Injury
    Date Received
    November 10, 2020
    Report Date
    November 9, 2020
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, 75 PEDIATRIC PATIENTS WERE IMPLANTED WITH MECHANICAL HEART VALVES BETWEEN 1995 AND 2019. 74 OF THE MECHANICAL HEART VALVES IMPLANTED WERE ST. JUDE MEDICAL PRODUCTS. 1 PATIENT HAD AN EVENT OF BLEEDING, 5 PATIENTS HAD ATRIOVENTRICULAR BLOCK, 1 PATIENT HAD MITRAL VALVE THROMBOSIS, 2 PATIENTS REQUIRED PERICARDIAL DRAINAGE, 2 PATIENTS REQUIRED EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, AND 18 PATIENTS REQUIRED ANOTHER OPERATION FOR A SECOND MECHANICAL HEART VALVE, WITH 1 PATIENT REQUIRING A THIRD MECHANICAL HEART VALVE OPERATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE ARTICLE "MECHANICAL MITRAL VALVE REPLACEMENTS IN THE PEDIATRIC POPULATION" WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE RANGE OF PROSTHETIC SIZE-TO-WEIGHT RATIO TO OPTIMIZE VALVE SURVIVAL IN SMALL CHILDREN. ABBOTT MECHANICAL HEART VALVES AND ON-X VALVES WERE ASSOCIATED TO THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT PATIENTS¿ INCREASED PROSTHESIS VALVE SIZE-TO-WEIGHT RATIO IS ASSOCIATED WITH INCREASED RISK OF REOPERATION AND AN INCREASE IN 1-2 TIMES THIS RATIO WOULD SUGGEST LONGER REINTERVENTION-FREE SURVIVAL IN SMALL CHILDREN WEIGHING =35KG. THE PRIMARY AUTHOR OF THE ARTICLE IS CHRISTOPHER IBARRA, MD OF DIVISION OF CONGENITAL HEART SURGERY, TEXAS CHILDREN¿S HOSPITAL. THE CORRESPONDENCE AUTHOR IS MICHIAKI IMAMURA, MD OF DIVISION OF CONGENITAL HEART SURGERY, TEXAS CHILDREN¿S HOSPITAL WITH THE CORRESPONDING EMAIL: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282844 SJM MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention