BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MECHANICAL HEART VALVE

    MDR report key: 17904715 · Received October 10, 2023

    Report

    Report Number
    2135147-2023-04407
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    March 1, 1990
    Report Date
    October 10, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF OUTCOMES AFTER MECHANICAL AORTIC VALVE REPLACEMENT IN CHILDREN WITH CONGENITAL HEART DISEASE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING AORTIC STENOSIS, AORTIC REGURGITATION, BICUSPID/QUADRICUSPID AORTIC VALVES, CONGENITAL AORTIC VALVE DISEASE, CONOTRUNCAL ANOMALY, CONNECTIVE TISSUE DISORDER, MARFAN SYNDROME, LOEYS-DIETZ SYNDROME, TURNER SYNDROME, NOONAN SYNDROME/CHARGE SYNDROME, PRIOR CATHETER-BASED OR SURGICAL INTERVENTION, PRIOR PROCEDURE FOR AORTIC VALVE. SOME OF THE COMPLICATIONS REPORTED WERE DEATH, HEART FAILURE, VENTRICULAR TACHYCARDIA, SURGICAL INTERVENTION, HOSPITALIZATION, PANNUS THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. THE ADDITIONAL PATIENT EFFECTS AND MALFUNCTIONS REPORTED IN THE ARTICLE ARE CAPTURED UNDER SEPARATE REPORTS. LITERATURE ATTACHMENT: ARTICLE TITLE: OUTCOMES AFTER MECHANICAL AORTIC VALVE REPLACEMENT IN CHILDREN WITH CONGENITAL HEART DISEASE.

    Description of Event or Problem · 0

    THE ARTICLE, ¿OUTCOMES AFTER MECHANICAL AORTIC VALVE REPLACEMENT IN CHILDREN WITH CONGENITAL HEART DISEASE¿, WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE SINGLE CENTER STUDY THAT INVESTIGATED THE OUTCOMES FOLLOWING AVR USING MECHANICAL PROSTHESES IN CHILDREN. DEVICES INCLUDED IN THIS STUDY WERE ST. JUDE (ABBOTT, SANTA CLARA, CA, USA), ON-X (CRYOLIFE, KENNESAW, GA, USA), ATS (MEDTRONIC, MINNEAPOLIS, MN, USA), AND MIRA (EDWARD LIFESCIENCES, IRVINE, CA, USA). THE ARTICLE CONCLUDED MECHANICAL AVR COULD BE PERFORMED SAFELY IN CHILDREN. YOUNGER AGE, LONGER CARDIOPULMONARY BYPASS TIME AND SMALLER VALVE SIZE WERE ASSOCIATED WITH ADVERSE EVENTS. THROMBOEMBOLIC OR HEMORRHAGIC COMPLICATIONS MIGHT RARELY OCCUR. [THE PRIMARY AND CORRESPONDING AUTHOR WAS CHUN SOO PARK, DIVISION OF PEDIATRIC CARDIAC SURGERY, ASAN MEDICAL CENTER, UNIVERSITY OF ULSAN COLLEGE OF MEDICINE, SEOUL, WITH CORRESPONDING EMAIL: [email protected]]

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332165 UNKNOWN MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L| H