BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE HEART VALVE

    MDR report key: 12027186 · Received June 18, 2021

    Report

    Report Number
    2015691-2021-03670
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 24, 2021
    Report Date
    July 14, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D4 EXPIRATION DATE, H4, H6 TYPE OF INVESTIGATION. 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

    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). 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. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT. THE ROOT CAUSE OF THIS EVENT WAS MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT'S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT STRUCTURAL VALVE DETERIORATION AND/OR NONSTRUCTURAL DYSFUNCTION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A 23 MM 8300ACD AORTIC VALVE IMPLANTED FOR 7 YEARS AND 7 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO CALCIFICATION, MILD TO MODERATE PARAVALVULAR LEAK, SEVERE STENOSIS, MODERATE REGURGITATION, FIBROSIS, AND LITTLE TO NO MOVEMENT OF THE LEAFLETS. PATIENT PRESENTED WITH RECURRENT CHF. THE PROCEDURE WAS PERFORMED WITH A NON-EDWARDS 26MM AORTIC TRANSCATHETER VALVE. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSPORTED TO THE CVR UNIT POSTOPERATIVELY IN STABLE CONDITION. THE PATIENT WAS DISCHARGED HOME ON POD #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922410 TISSUE HEART VALVE LWR EDWARDS LIFESCIENCES 8300ACD NA

    Patients

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