BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 10876827 · Received November 20, 2020

    Report

    Report Number
    2015691-2020-14545
    Event Type
    Injury
    Date Received
    November 20, 2020
    Date of Event
    October 13, 2020
    Report Date
    October 28, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION IS IN PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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/RING. 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. THE CAUSE OF THE EVENT CANNOT BE DETERMINED. 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. ARTICLE CITATION: DE MARTINO, ANDREA, FALCETTA GIOSUE, ET AL. EARLY VALVE THROMBOSIS IN SURGICAL AORTIC BIOPROSTHESIS. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. VOL. 76, NO. 15 2020:1808-14.

    Description of Event or Problem · 1

    THROUGH REVIEW OF MEDICAL ARTICLE "EARLY VALVE THROMBOSIS IN SURGICAL AORTIC VALVES", THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: A (B)(6) YEAR OLD MAN WITH AN AORTIC PERICARDIAL VALVE PRESENTED WITH INCREASE IN AORTIC TRANSVALVULAR GRADIENTS WITH NO EVIDENT THICKENING OR HYPOMOBILITY OF THE CUSPS. THE ISSUE WAS OBSERVED ON A POST-OPERATIVE ECHOCARDIOGRAM. A CT REVEALED THE PRESENCE OF THICKENING OF THE NONCORONARY CUSP. WARFARIN ANTICOAGULANT THERAPY WAS INSTITUTED. THE PRESENT REPORT SHOWED THE FIRST CASE OF HYPOATTENUATED LEAFLET THICKENING (HALT) WITH A LAST-GENERATION BIOPROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344271 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R