BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 11880632 · Received May 25, 2021

    Report

    Report Number
    2015691-2021-03142
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Report Date
    July 1, 2021
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    LWR
    PMA / PMN Number
    P150048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: ADDED INFORMATION TO B5, B7, D4.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: ADDED INFORMATION TO D4, H4,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.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH A 23MM AORTIC VALVE IMPLANTED IN THE AORTIC POSITION HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS AND 2 MONTHS DUE TO DEGENERATION LEADING TO STENOSIS. THE PATIENT PRESENTED WITH AORTIC STENOSIS WITH GRADIENTS 37/21MMHG AND EOA 1,4CM2. AN AVR WITH DESCENDENT AORTA REPLACEMENT DUE TO AORTIC DISSECTION TYPE A WAS PERFORMED DURING INITIAL SURGERY.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION IS IN PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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 CAUSE OF THE EVENT CANNOT BE DETERMINED. 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 NOTIFICATION THAT DEGENERATION WAS OBSERVED ON AN 23MM AORTIC VALVE AFTER AN IMPLANT DURATION OF 2 YEARS AND 2 MONTHS. THE PATIENT PRESENTED WITH AORTIC STENOSIS WITH GRADIENTS 37/21MMHG AND EOA 1,4CM2. THE PATIENT WAS NOT RE-OPERATED AT THIS TIME. AN AVR WITH DESCENDENT AORTA REPLACEMENT DUE TO AORTIC DISSECTION TYPE A WAS PERFORMED DURING INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771754 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES LLC 11500A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR