BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 11245222 · Received January 28, 2021

    Report

    Report Number
    2015691-2021-01038
    Event Type
    Injury
    Date Received
    January 28, 2021
    Date of Event
    January 4, 2021
    Report Date
    February 23, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS D4 EXPIRATION DATE, H4, AND H6. THE DEVICE HISTORY RECORD 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.

    Additional Manufacturer Narrative · 1

    PMA/510(K): 8300ACA- THIS DEVICE IS NOT SOLD OR MARKETED IN THE U.S.; HOWEVER, IT IS SIMILAR TO DEVICE MODEL 8300AB, EDWARDS INTUITY ELITE VALVE (PMA P150036). THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. 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 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

    (B)(4): IT WAS REPORTED THAT A CLINICAL TRIAL PATIENT WITH A 19MM 8300ACA AORTIC VALVE IMPLANTED FOR SEVEN YEARS, NINE MONTHS UNDERWENT REDO AVR DUE TO CALCIFICATION, SEVERE STENOSIS, AND DECREASED LEAFLET EXCURSION DETECTED BY ECHO. A 21MM 8300AB VALVE WAS IMPLANTED IN REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140222 NA REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 8300ACA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R