BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 16976349 · Received May 22, 2023

    Report

    Report Number
    2015691-2023-13154
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    April 11, 2023
    Report Date
    July 10, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103194982
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: 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.

    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. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS LEARNED VIA THE IMPLANT PATIENT REGISTRY THAT AN 11500A 23MM INSPIRIS RESILIA AORTIC VALVE [2023-09826-02] AND 7300TFX 31MM BIOPROSTHETIC MITRAL VALVE [2023-09826-01], BOTH IMPLANTED FOR ONE (1) MONTH, WERE EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICES WERE REPLACED WITH AN 11500A 25MM INSPIRIS RESILIA AORTIC VALVE AND 11400M 29MM MITRIS RESILIA MITRAL VALVE RESPECTIVELY. POST OP PATIENT'S STATUS NOTED IN RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862812 INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A23 00690103194982

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization| R| L