BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 10836630 · Received November 13, 2020

    Report

    Report Number
    2015691-2020-14364
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    September 10, 2020
    Report Date
    October 21, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10. UPDATED B6.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE U.S.; HOWEVER, IT IS SIMILAR TO DEVICE MODEL 11500A, EDWARDS INSPIRIS RESILIA AORTIC VALVE (PMA P150048). THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. 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 25MM VALVE IMPLANTED FOR SIX YEARS, THREE MONTHS WAS EXPLANTED DUE TO CALCIFICATION, PANNUS, STRUCTURAL VALVE DETERIORATION, AND SEVERE AORTIC STENOSIS. A 21MM NON-EDWARDS MECHANICAL VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT WAS DISCHARGED ON POD #11 IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301389 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 11000A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R