BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART-VALVE, REPLACEMENT

    MDR report key: 8945172 · Received August 29, 2019

    Report

    Report Number
    2015691-2019-03235
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    July 30, 2019
    Report Date
    August 6, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    PMA/510(K): 8300ACD- THIS DEVICE IS NOT SOLD OR MARKETED IN THE U.S.; HOWEVER, IT IS SIMILAR TO DEVICE MODEL 8300AB, EDWARDS INTUITY ELITE VALVE SYSTEM (PMA P150036). THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. 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. A MANUFACTURING RELATED ISSUE WAS NOT IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A 23MM AORTIC VALVE DEVELOPED THROMBOSIS AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS. PATIENT WAS STARTED ON COUMADIN AND WILL HAVE A FOLLOW UP TEE IN 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739933 HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 8300ACD23

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention