BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC¿ VALVE (AORTIC)

    MDR report key: 17213062 · Received June 27, 2023

    Report

    Report Number
    2135147-2023-02811
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    June 12, 2023
    Report Date
    November 30, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE: INNOVATIVE USE OF A SELF-EXPANDING VALVE FOR VALVE-IN-VALVE TRANSCATHETER MITRAL VALVE REPLACEMENT: EXPERIENCE FROM A FOUR-YEAR SINGLE-CENTER STUDY. SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS DUE TO REPLACEMENT OF AN IMPLANTED SURGICAL VALVE WITH A TRANSCATHETER COMPETITORS' J-VALVE WERE REPORTED IN A RESEARCH ARTICLE. THE SUBJECT POPULATION HAD MULTIPLE CO-MORBIDITIES INCLUDING CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, PREVIOUS CORONARY ARTERY BYPASS, PRIOR CVA/TIA, PERIPHERAL VASCULAR DISEASE, CURRENTLY RECEIVING DIALYSIS, DIABETES MELLITUS, HYPERTENSION, ATRIAL FIBRILLATION AND PREVIOUS PERMANENT PACEMAKER. SOME OF THE REASONS FOR REPLACING THE SURGICAL VALVES WERE STENOSIS, REGURGITATION, SURGICAL INTERVENTION, HOSPITALIZATION, STROKE AND PARAVALVULAR LEAK. 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.

    Description of Event or Problem · 0

    THE ARTICLE, "INNOVATIVE USE OF A SELF-EXPANDING VALVE FOR VALVE-IN-VALVE TRANSCATHETER MITRAL VALVE REPLACEMENT: EXPERIENCE FROM A FOUR-YEAR SINGLE-CENTER STUDY", WAS REVIEWED. THE ARTICLE PRESENTS A RETROSPECTIVE, SINGLE CENTER STUDY EXPERIENCE TO EXPLORE THE EFFECTIVENESS AND SAFETY OF J-VALVE AND REPORT THE RESULTS FROM THE FOUR-YEAR FOLLOW-UP PERIOD OF THE INNOVATIVE APPLICATION OF THE TRANSCATHETER VALVE. DEVICE THAT WERE INCLUDED IN THIS STUDY WERE CARPENTIER-EDWARDS PORCINE AND PERICARDIAL (EDWARDS LIFESCIENCES, INC., IRVINE, CA, USA), HANCOCK II AND MOSAIC (MEDTRONIC, MINNEAPOLIS, MN, USA), EPIC HEART VALVE (ST JUDE MEDICAL, INC, ST PAUL, MN, USA), BALMEDIC BOVINE PERICARDIAL (BALANCE MEDICAL, BEIJING, CHINA), AND J-VALVE (JC MEDICAL INC., SUZHOU, CHINA). THE ARTICLE CONCLUDED THE J-VALVE SYSTEM IS A SAFE AND EFFECTIVE OPTION FOR VIV-TMVR: IT HAS A HIGH SUCCESS RATE AND LOW MORTALITY, AND RESULTED IN VERY FEW COMPLICATIONS. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2019 AND SEPTEMBER 2022. THE NUMBER OF PATIENTS INCLUDED IN THIS STUDY WAS 33 WITH THE AVERAGE AGE BEING 70.1 YEARS AND THE AVERAGE GENDER BEING FEMALE. COMORBIDITIES INCLUDED CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CORONARY ARTERY DISEASE, PREVIOUS CORONARY ARTERY BYPASS, PRIOR CVA/TIA, PERIPHERAL VASCULAR DISEASE, CURRENTLY RECEIVING DIALYSIS, DIABETES MELLITUS, HYPERTENSION, ATRIAL FIBRILLATION, PREVIOUS PERMANENT PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68593 EPIC¿ VALVE (AORTIC) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R| S| H