BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX AORTIC ANATOMIC EXT 23

    MDR report key: 22480926 · Received July 11, 2025

    Report

    Report Number
    1649833-2025-00025
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    February 5, 2025
    Report Date
    September 9, 2025
    Manufacturer
    ONX LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001662
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    ACCORDING TO THE INITIAL REPORT RECEIVED ON 30JUN2025, "RECEIVED AN AORTIC IMPLANT FOR PATIENT WITH EXISTING AORTIC IMPLANT (13 DAY REDO)". THE MANUFACTURING RECORDS FOR ONXANE-23, SN A0814604 WERE REVIEWED. 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-CONFORMANCES OR DEVIATIONS WERE FOUND. THE AVAILABLE INFORMATION WAS REVIEWED. ON (B)(6) 2025 AN ONXANE-23 SN (B)(6) WAS USED IN A CASE FOR A 69-YEAR-OLD MALE IN THE AORTIC POSITION. A SECOND AORTIC ON-X WAS REPORTED TO DEVICE TRACKING ON (B)(6) 2025 AS IMPLANTED IN THE SAME POSITION, SAME PATIENT: (B)(6) 2025 ONXANE-23 SN (B)(6) (13 DAYS POST-IMPLANT). MULTIPLE ATTEMPTS TO RECEIVE ADDITIONAL INFORMATION RECEIVED NO RESPONSE. REVIEW OF MANUFACTURING RECORDS SHOW NO PROCESSING ISSUES WITH THE ORIGINAL VALVE. THE VALVE WAS NOT RETURNED TO THE MANUFACTURER FOR EXAMINATION. WE HAVE NO INFORMATION ABOUT THE EXPLANTED ON-X VALVE OTHER THAN THE TRACKING NOTICE AND ASSUME THE VALVE WAS DISCARDED ON SITE. CONSEQUENTLY, WE DO NOT HAVE ENOUGH INFORMATION TO KNOW WHAT, IF ANY, CONTRIBUTION THE VALVE HAD TO THE DECISION TO REPLACE IT. THE INSTRUCTIONS FOR USE FOR THE ON-X VALVE LISTS THE POSSIBILITY OF EXPLANTATION AS A CONSEQUENCE OF A COMPLICATION OF PROSTHETIC HEART VALVE REPLACEMENT [IFU]. BUT IN THIS INSTANCE, WE DO NOT HAVE ANY INFORMATION TO HELP US IDENTIFY THAT COMPLICATION. 05SEP2025 UPDATE: ON (B)(6)2025 THE IMPLANTING SURGEON CLARIFIED THAT THE EXPLANTATION OF THE ONX VALVE WAS NOT DUE TO ANY VALVE-RELATED ISSUE. THE EXPLANT WAS PERFORMED TO ACCESS AND REPAIR DAMAGE TO THE MITRAL VALVE THAT HAD OCCURRED DURING THE ORIGINAL PROCEDURE PERFORMED BY ANOTHER SURGEON. THE SURGEON CONFIRMED THAT THIS WAS A PURELY TECHNICAL MISHAP (DAMAGE TO THE MITRAL VALVE) AND WAS UNRELATED TO THE ONX VALVE ITSELF. ACCORDINGLY, THE ROOT CAUSE HAS BEEN UPDATED TO REFLECT THAT THE EVENT WAS NOT DEVICE-RELATED BUT THE RESULT OF A SURGICAL COMPLICATION DURING THE PRIOR IMPLANT PROCEDURE. WITH THE IMPLANTING SURGEON STATING THAT THE EXPLANT OF THE ON-X AORTIC VALVE WAS PERFORMED SOLELY TO ALLOW ACCESS FOR REPAIR OF A DAMAGED MITRAL VALVE, WE CAN CONCLUDE THAT THE ON-X AORTIC VALVE DID NOT CONTRIBUTE TO THE NEED FOR EXPLANTATION. NO FURTHER ACTION IS REQUIRED WITHOUT FURTHER INFORMATION. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR THIS EVENT IS SURGICAL REPAIR OF PATIENT¿S NATIVE TISSUE. THE IMPLANTING SURGEON STATING THAT THE EXPLANT OF THE ON-X AORTIC VALVE WAS PERFORMED SOLELY TO ALLOW ACCESS FOR REPAIR OF A DAMAGED MITRAL VALVE, WE CAN CONCLUDE THAT THE ON-X AORTIC VALVE DID NOT CONTRIBUTE TO THE NEED FOR EXPLANTATION. THE MANUFACTURING RECORDS 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. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK. ARTIVION WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. 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 RECEIVED ON (B)(6) 2025 "RECEIVED AN AORTIC IMPLANT FOR PATIENT WITH EXISTING AORTIC IMPLANT (13 DAY REDO)". THIS INVESTIGATION IS RELEGATED TO ONX AORTIC VALVE, ONXANE-23, SERIAL NUMBER A0814604 THAT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948754 ONX AORTIC ANATOMIC EXT 23 HEART-VALVE, MECHANICAL LWQ ONX LIFE TECHNOLOGIES, INC. ONXANE-23 00851788001662

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention