BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 4877036 · Received June 30, 2015

    Report

    Report Number
    2015691-2015-01566
    Event Type
    Injury
    Date Received
    June 30, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE THE DEVICE AND ADDITIONAL INFORMATION ARE IN PROCESS. WITHOUT DEVICE RETURN OR ADDITIONAL INFORMATION THE ROOT CAUSE OF THE REPORTED EVENT IS INDETERMINABLE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A (B)(4) BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    ARTICLE: "EARLY BIOPROSTHESIS FAILURE: REPORT OF THREE CASES AND LITERATURE REVIEW PUBLISHED BY FORUM MULTIMEDIA PUBLISHING, LLC, DOI: 10.1532/HSF.1242. ABSTRACT - BACKGROUND: WE EXPERIENCED THREE RARE EARLY BIOPROSTHESIS FAILURE (EBF) CASES. IN THIS STUDY, WE ANALYZE THE CAUSES AND DISCUSS THE COPING STRATEGY OF EBF. METHODS: WE REVIEWED ALL CASES OF EBF IN PATIENTS WHO RECEIVED A BIOPROSTHESIS REPLACEMENT IN CHANGHAI HOSPITAL BETWEEN JANUARY 2001 AND JANUARY 2014, AND REVIEWED RELATED ARTICLES THAT WERE PUBLISHED BETWEEN 1994 AND 2014, SEARCHING FOR KEYWORDS IN PUBMED SUCH AS ¿BIOPROSTHESIS,¿ ¿HEART VALVE PROSTHESIS,¿ ¿EARLY FAILURE,¿ AND ¿BIOPROSTHESIS FAILURE.¿ RESULTS: ONLY THREE CASES WERE FOUND IN CHANGHAI HOSPITAL DURING THIS TIME PERIOD. THE REASONS FOR EBF IN THESE 3 CASES WERE: NATIVE VALVE ATTACHMENT, EARLY CALCIFICATION CAUSED BY METABOLIC SYNDROME, AND EARLY VALVE THROMBOSIS. LITERATURE REVIEW IDENTIFIED ADDITIONAL 14 CASES. THE REASONS FOR EBF IN THESE 14 CASES WERE AS FOLLOWS: NATIVE VALVE ATTACHMENT IN 6 CASES; METABOLIC ABNORMALITIES IN 3 CASES; EARLY VALVE THROMBOSIS IN 2 CASES; CHRONIC INFLAMMATION IN 2 CASES; AND IMPROPER OPERATION IN 1 CASE. CONCLUSION: EBF IS A RARE BUT SERIOUS COMPLICATION. THE CAUSE OF EBF IS COMPLEX. APPROPRIATE PREVENTIVE MEASURES SHOULD BE DEVELOPED ACCORDING TO THE CONDITION OF THE PATIENT. THIS REPORT IS FOR A (B)(6) MALE PATIENT WHO UNDERWENT RE-DO MITRAL VALVE REPLACEMENT OF HIS EDWARDS PERIMOUNT MAGNA VALVE AFTER AN IMPLANT DURATION OF FOUR (4) DAYS DUE TO LEAFLET ADHESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421697 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R