BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 8650710 · Received May 29, 2019

    Report

    Report Number
    2015691-2019-01891
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    January 26, 2017
    Report Date
    August 4, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    MODEL #: THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #11500A; BRAND NAME: EDWARDS INSPIRIS RESILIA AORTIC VALVE; PMA #P150048. 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. 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. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINED IMPLANTED. THEREFORE, THE ROOT CAUSE FOR THE STENOSIS REMAINS INDETERMINABLE. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. 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 · 1

    EDWARDS RECEIVED INFORMATION THROUGH A CLINICAL TRIAL THAT A PATIENT WITH A 23MM AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 10 MONTHS DUE TO MODERATE PULMONARY REGURGITATION AND MODERATE PULMONARY STENOSIS. THE TPVR WAS PERFORMED WITH A 26MM SUCCESSFULLY. THE VALVE WAS POST DILATED WITH A 24MM TRUE BALLOON AT 15 ATM RESULTING IN FRACTURE OF THE SURGICAL VALVE RING. POST PROCEDURE ECHO DEMONSTRATED A STABLE VALVE PROSTHESIS WITHOUT SIGNIFICANT PULMONARY STENOSIS OR PULMONARY REGURGITATION. NO PERIVALVULAR LEAK WAS IDENTIFIED. THE PATIENT WAS DISCHARGED HOME ON POD #1 IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442442 REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 11000A23MM

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R