BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX ASCENDING AORTIC 27/29

    MDR report key: 19557946 · Received June 18, 2024

    Report

    Report Number
    1649833-2024-00036
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 18, 2024
    Report Date
    July 29, 2024
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS FOR ONXAAP-27/29, SN: (B)(6) WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. DURING THE INVESTIGATION NO NON-CONFORMANCE'S OR DEVIATIONS WERE NOTED. CHANGE ORDER(S) FOR LEAFLET TUNING ARE PERFORMED AS A PART OF THE STANDARD MANUFACTURING PROCESS. AN ONXAAP-27/29, SERIAL NUMBER: (B)(6) WAS IMPLANTED ON (B)(6) 2022 IN A 57 YEAR OLD MALE AND 723 DAYS POST-IMPLANT IT WAS EXPLANTED AND REPLACED WITH ONXAAP-25, SERIAL NUMBER: (B)(6). INFORMATION FROM THE SURGEON INDICATED THAT THE VALVE HAD BEEN REMOVED DUE TO ENDOCARDITIS AND THAT THE PATIENT WAS DOING FINE. THE EXPLANTED VALVE WAS NOT RETURNED TO THE MANUFACTURER FOR EXAMINATION. NO FURTHER INFORMATION WAS PROVIDED, AND NO MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. A REVIEW OF THE ORIGINAL MANUFACTURING RECORDS SHOWS NO ABNORMALITIES. WITH THE INFORMATION PROVIDED, THE SOURCE OF THE ENDOCARDITIS IS UNKNOWN. HOWEVER, BECAUSE ALL ON X VALVES UNDERGO VALIDATED TERMINAL STERILIZATION PRIOR TO DISTRIBUTION, THE VALVE IS UNLIKELY TO BE THE SOURCE OF THE INFECTION. THE INSTRUCTIONS FOR USE (IFU) FOR THE ON-X VALVE STATES THAT REOPERATION, INCLUDING EXPLANTATION, MAY RESULT FROM A COMPLICATION, IN THIS CASE, ENDOCARDITIS, A KNOWN POTENTIAL EVENT ACKNOWLEDGED IN THE IFU. THOUGH RARE, HISTORICALLY, ENDOCARDITIS OCCURS AT A RATE OF (B)(4)/PATIENT-YEAR FOR MECHANICAL AORTIC HEART VALVES [ISO 5840-2:2021]. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, THIS VALVE WAS EXPLANTED DUE TO ENDOCARDITIS. A NEW VALVE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. THIS VALVE IS NOT EXPECTED TO BE RETURNED FOR ARTIVION, INC FOR ANALYSIS.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, THIS VALVE WAS EXPLANTED DUE TO ENDOCARDITIS. A NEW VALVE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. THIS VALVE IS NOT EXPECTED TO BE RETURNED FOR ARTIVION, INC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332660 ONX ASCENDING AORTIC 27/29 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAAP-27/29

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| H