BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTUITY VALVE SYSTEM AORTIC VALVE

    MDR report key: 15853500 · Received November 23, 2022

    Report

    Report Number
    2015691-2022-09445
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    November 1, 2022
    Report Date
    January 5, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND EDWARDS INTUITY ELITE VALVE SYSTEM, MODEL# 8300AB, PMA# P150036. STENOSIS, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. STRUCTURAL VALVE DETERIORATION (SVD), A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. STENOSIS IS MOST COMMONLY RELATED TO PATIENT FACTORS, AND IS NOT USUALLY AN INDICATION OF A DEVICE MALFUNCTION. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    UPDATED D4, H4, AND H6 PER NEW INFORMATION RECEIVED. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT FACTORS LIKELY CAUSED OR CONTRIBUTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING AND STERILIZATION SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 21MM AORTIC VALVE IS BEING EVALUATED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS DUE TO STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308950 EDWARDS INTUITY VALVE SYSTEM AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 8300ACD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| L| H