BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KONECT RESILIA AORTIC VALVED CONDUIT AVC

    MDR report key: 23058609 · Received September 15, 2025

    Report

    Report Number
    2015691-2025-07597
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    September 17, 2021
    Report Date
    November 6, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103201390
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS G3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT WAS UNABLE TO BE CONFIRMED, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. AN EDWARDS DEFECT HAS NOT BEEN CONFIRMED. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED, AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED TYPE OF EVENT IS INCLUDED IN THE IFU. 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. THE SUBJECT DEVICE SUCCESSFULLY PASSED VISUAL INSPECTIONS FOR GRAFT TEARS AND LOOSE PARTICULATES. NO ADDITIONAL SIMILAR COMPLAINTS WERE IDENTIFIED RELATED TO THE MANUFACTURING LOTS ASSOCIATED WITH THE SUBJECT COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    H11: 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.

    Description of Event or Problem · 0

    IT WAS LEARNED FROM A RETROSPECTIVE CLINICAL TRIAL THAT A PATIENT WITH A 27MM 11060A KONECT RESILIA AORTIC VALVED CONDUIT (AVC) EXHIBITED BLEEDING AND TAMPONADE REQUIRING REOPERATION FOR REINTERVENTION ON THE GRAFT ONLY ON POD #1. THE DEVICE REMAINED IMPLANTED. ON POD #8, PATIENT HAD A TTE WHICH DEMONSTRATED AORTIC MEAN GRADIENT OF 8 MMHG, EOA 2.6 CM2, AND LVEF OF 55%. THE PATIENT WAS DISCHARGED TO AN ACUTE CARE HOSPITAL ON POD #18. ON 1-YEAR FOLLOW-UP CT, IT SHOWED NO ABNORMALITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398658 KONECT RESILIA AORTIC VALVED CONDUIT AVC HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11060A 00690103201390

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Life Threatening| H| R