BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 12625717 · Received October 13, 2021

    Report

    Report Number
    2015691-2021-05652
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    September 10, 2021
    Report Date
    October 13, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANT OF A 25MM 11500A INSPIRIS VALVE. A LARGE JET WAS OBSERVED AT THE ANTERIOR STENT POST. THE JET DID NOT RESOLVE WITH PROTAMINE ADMINISTRATION. THERE WAS NO SIGNIFICANT GRADIENT AND NO PVL. THE PATIENT IS REPORTED TO BE DOING WELL. AS REPORTED, IF THE JET DOES NOT RESOLVE IN ONE MONTH THE PLAN IS FOR THE PATIENT TO UNDERGO REPLACEMENT OF THE INSPIRIS VALVE. THE PATIENT HAD TRANSIENT POST-OPERATIVE ATRIAL FIBRILLATION TREATED WITH AMIODARONE. THE PATIENT WAS DISCHARGED ON POD # 13. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520558 EDWARDS INSPIRIS RESILIA AORTIC VALVE REPLACEMENT HEART-VALVE LWR EDWARDS LIFESCIENCES 11500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR