BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 12761873 · Received November 7, 2021

    Report

    Report Number
    2015691-2021-06192
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    September 22, 2021
    Report Date
    December 15, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103195002
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. MULTIPLE REQUESTS FOR ADDITIONAL DETAILS REGARDING THIS EVENT (I.E., MEDICAL RECORDS) HAVE BEEN PERFORMED; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE SUBJECT DEVICE IS ALSO UNAVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. THERE IS CURRENTLY INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 0

    BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR REGURGITATION AND/OR STENOSIS. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    THROUGH THE IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT 27MM 11500 INSPIRIS RESILIA AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 11 MONTHS, 23 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500 INSPIRIS RESILIA AORTIC VALVE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. EDWARDS LIFESCIENCES LLC., MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662693 INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A NA 00690103195002

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Hospitalization| R| L