BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC STENTED TISSUE VALVE

    MDR report key: 11564117 · Received March 24, 2021

    Report

    Report Number
    3001883144-2021-00041
    Event Type
    Injury
    Date Received
    March 24, 2021
    Report Date
    April 20, 2021
    Manufacturer
    ST. JUDE MEDICAL, BRASIL LTDA.
    Product Code
    LWR
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, 424.PATIENTS UNDERWENT MITRAL VALVE REPLACEMENT WITH A MECHANICAL VALVE (ABBOTT), REGENT VALVE (ABBOTT), EPIC VALVE (ABBOTT), MOSAIC (MEDTRONIC), MAGNA (EDWARDS LIFESCIENCES), CE-PERICARDIAL (EDWARDS LIFESCIENCES), RESILIA (EDWARD LIFESCIENCES), ATS-AP-360 (ATS MEDICAL, INC), MED ADVANTAGE, OR ON-X (CRYOLIFE). EVENTS OF STROKE, TRANSIENT ISCHEMIC ATTACK, DEEP STERNAL WOUND INFECTION, ATRIAL FIBRILLATION, RENAL FAILURE, BLEEDING, INTUBATION GREATER THAN 48 HOURS, AND LOW CARDIAC OUTPUT STATE WERE REPORTED. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE NUMBER : 2648612-2021-00028.THE ARTICLE, "PROSTHETIC CHOICE IN MITRAL VALVE REPLACEMENT FOR SEVERE CHRONIC ISCHEMIC MITRAL REGURGITATION: LONG-TERM FOLLOW-UP", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO ASSESS AND COMPARE SHORT AND LONG-TERM OUTCOMES AFTER MITRAL VALVE REPLACEMENT (MVR) AMONG PATIENTS WITH BIOLOGICAL (BP) OR MECHANICAL (MP) PROSTHESES IN THE SETTING OF SEVERE ISCHEMIC MITRAL REGURGITATION (IMR). DEVICES INVOLVED INCLUDED MECHANICAL VALVE (ABBOTT), REGENT VALVE (ABBOTT), EPIC VALVE (ABBOTT), MOSAIC (MEDTRONIC), MAGNA (EDWARDS LIFESCIENCES), CE-PERICARDIAL (EDWARDS LIFESCIENCES), RESILIA (EDWARD LIFESCIENCES), ATS-AP-360 (ATS MEDICAL, INC), MED ADVANTAGE, AND ON-X (CRYOLIFE). THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICES. THE ARTICLE CONCLUDED THAT SHORT-TERM OUTCOMES AND SURVIVAL ARE SIMILAR BETWEEN PROSTHESIS TYPES, BUT LONG TERM CARDIOVASCULAR RISK IS HIGHER IN MECHANICAL VALVES. LONG-TERM ALL-CAUSE MORTALITY IS SIMILAR BETWEEN BIOLOGICAL AND MECHANICAL PROSTHESIS IN SEVERE ISCHEMIC MITRAL REGURGITATION. HOWEVER, NEUROLOGIC OR BLEEDING RISK ARE HIGHER IN MECHANICAL PROSTHESIS. THE PRIMARY AUTHOR IS JEREMY BERNARD, MSC, FROM THE DEPARTMENTS OF CARDIOLOGY OF THE QUEBEC HEART AND LUNG 6 INSTITUTE, LAVAL UNIVERSITY, QUEBEC CITY, QUEBEC, CANADA. THE CORRESPONDENCE AUTHOR IS DR. SIAMAK MOHAMMADI, MD, DEPARTMENT OF CARDIAC SURGERY, QUEBEC HEART AND LUNG INSTITUTE, 2725, CHEMIN SAINTE-FOY, QUEBEC CITY, QUEBEC, CANADA, G1V 4G5, WITH THE CORRESPONDING EMAIL: [email protected], PHONE: +011(418)6564717

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457217 EPIC STENTED TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, BRASIL LTDA.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R