BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX AORTIC ANATOMIC EXT 21

    MDR report key: 17197483 · Received June 26, 2023

    Report

    Report Number
    1649833-2023-00016
    Event Type
    Injury
    Date Received
    June 26, 2023
    Date of Event
    May 26, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001419
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 ONXANE-21 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. ONXANE 21 SN: (B)(6) WAS IMPLANTED ON (B)(6) 2022 IN A 58 YEAR OLD FEMALE WITH A MEDICAL HISTORY OF BICUSPID AORTIC VALVE AND ASCENDING AORTIC ANEURYSM IN A CONCOMITANT PROCEDURE WITH A HEMI-ARCH REPAIR WITH A 24MM GRAFT. ACCORDING TO A REPORT MADE BY THE SURGEON THROUGH A SALE REPRESENTATIVE, THIS VALVE WAS EXPLANTED ON (B)(6) 2023 (284 DAYS POST-IMPLANT) AND REPLACED WITH ONXAAP-21. INFORMATION FROM THE SURGEON INDICATED THAT THE VALVE HAD BEEN REMOVED DUE TO ENDOCARDITIS. NO MEDICAL RECORDS OR OPERATIVE NOTES WERE PROVIDED TO THE MANUFACTURER AND THE EXPLANTED VALVE WAS NOT RETURNED FOR EXAMINATION. A REVIEW OF THE ORIGINAL MANUFACTURING RECORDS SHOWS NO ABNORMALITIES. WITH THE INFORMATION AVAILABLE, THE SOURCE OF THE ENDOCARDITIS IS UNKNOWN. HOWEVER, BECAUSE THE ON-X VALVE MANUFACTURING PROCESS INCLUDES VALIDATED TERMINAL STERILIZATION PRIOR TO DISTRIBUTION-VERIFIED BY A REVIEW OF MANUFACTURING RECORDS UNIQUE TO THIS VALVE ¿ THE VALVE IS UNLIKELY TO BE THE SOURCE OF 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]. ENDOCARDITIS IS THE ROOT CAUSE FOR THE EXPLANTATION OF THE AORTIC ON-X VALVE. BECAUSE ALL ON-X VALVES UNDERGO VALIDATED TERMINAL STERILIZATION PRIOR TO DISTRIBUTION, THE VALVE IS UNLIKELY TO BE THE SOURCE OF THE INFECTION. 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 IMPLANTED ON (B)(6) 2022 AND REPLACED ON (B)(6) 2023 DUE TO ENDOCARDITIS.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, THIS VALVE WAS IMPLANTED ON (B)(6) 2022 AND REPLACED ON (B)(6) 2023 DUE TO ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930150 ONX AORTIC ANATOMIC EXT 21 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXANE-21 00851788001419

    Patients

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