BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 10486489 · Received September 3, 2020

    Report

    Report Number
    2015691-2020-13415
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 10, 2020
    Report Date
    August 12, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS B5, B7, F10, AND H6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 25MM VALVE IMPLANTED FOR FIVE YEARS, 29 DAYS HAD SEVERE CALCIFICATION, DEGENERATION, STENOSIS, THICKENED LEAFLETS WITH RESTRICTED MOBILITY, SEVERELY INCREASED GRADIENTS, AND MILD TO MODERATE CENTRAL REGURGITATION ON ECHOCARDIOGRAM. THE PATIENT IS ASYMPTOMATIC. THE PATIENT WILL UNDERGO CATHETERIZATION AS PART OF WORKUP FOR TAVR.

    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, PMA NUMBER 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. CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), AND MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. ALTHOUGH PATIENT FACTORS ARE BELIEVED TO PLAY A CRUCIAL ROLE IN THE DEVELOPMENT IN BIOPROSTHETIC TISSUE CALCIFICATION, THE UNDERLINE MECHANISM IS STILL NOT FULLY UNDERSTOOD. A MANUFACTURING RELATED ISSUE WAS NOT IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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 VALVE IMPLANTED FOR FIVE YEARS, 29 DAYS HAD STENOSIS AND CALCIFICATION ON ECHOCARDIOGRAM. THE PATIENT IS ASYMPTOMATIC. THE SURGEON WILL ASSESS THE TYPE OF SURGICAL PROCEDURE TO PERFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951586 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 8300ACD

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR