BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 8624380 · Received May 20, 2019

    Report

    Report Number
    2015691-2019-01798
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    February 1, 2018
    Report Date
    April 25, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    MODEL #: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #8300AB; BRAND NAME: EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE; PMA #P150036. VALVE THROMBOSIS IS A RARE AND WELL-RECOGNIZED COMPLICATION OF PROSTHETIC VALVES. VALVE THROMBOSIS IS THE FORMATION OF SIGNIFICANT BLOOD CLOTS FORMING ON THE VALVE. THESE CLOTS COULD SIGNIFICANTLY IMPACT THE FUNCTIONALITY OF THE VALVE RESULTING IN HEART FAILURE OR THROMBOEMBOLISM. IMMEDIATE INTERVENTION, EITHER BY THROMBOLYTIC THERAPY OR VALVE REPLACEMENT IS REQUIRED FOR SIGNIFICANT THROMBOSIS. ALTERNATIVELY, THERE MAY BE CASES WHERE THE PATIENT IS PLACED ON AN ANTICOAGULANT TO TREAT THROMBOSIS. IN THIS CASE, THE PATIENT MEDICAL INTERVENTION TO TREAT THE THROMBOSIS. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINED IMPLANTED. THEREFORE, THE ROOT CAUSE FOR THE EVENT REMAINS INDETERMINABLE. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING AND STERILIZATION SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFO VIA A CLINICAL TRIAL THAT A 25 AORTIC VALVE DEVELOPED SUBACUTE LEAFLET THROMBOSIS AFTER AN IMPLANT DURATION OF 3 YEARS, 4 MONTHS. WARFARIN WAS ADMINISTRATED. ABOUT 2 MONTHS AFTER THE THROMBOSIS WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417934 REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 8300ACD25

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R