BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX MITRAL CONFORM 25/33

    MDR report key: 15141957 · Received August 1, 2022

    Report

    Report Number
    1649833-2022-00044
    Event Type
    Injury
    Date Received
    August 1, 2022
    Date of Event
    May 27, 2022
    Report Date
    October 10, 2022
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001303
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS FOR ONXMC-25/33, SERIAL NUMBER (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. AN ONXMC ¿ 25/33 SN (B)(6) WAS IMPLANTED ON (B)(6) 2019 IN A 10-YEAR-OLD MALE. ACCORDING TO MANDATORY TRACKING INFORMATION RECEIVED FROM THE MANUFACTURER, THIS VALVE WAS EXPLANTED (B)(6) 2022 ( 881 DAYS POST-IMPLANT) AND REPLACED WITH ONXM -25 SN (B)(6). ADDITIONAL INFORMATION FROM THE CLINICAL MANAGER AT THE CARDIOTHORACIC OPERATING ROOM INDICATED THAT THE VALVE HAD BEEN REMOVED DUE TO NEW VEGETATION ON THE VALVE VERIFIED BY TEE (TRANS ESOPHAGEAL ECHOCARDIOGRAM) AND POSITIVE BLOOD CULTURES WERE ALSO REPORTED. OF NOTE, THE ORIGINAL VALVE WAS IMPLANTED DUE TO SEVERE MITRAL REGURGITATION WITH VEGETATION. THE EXPLANTED VALVE WAS NOT RETURNED TO THE MANUFACTURER FOR EXAMINATION AND A REVIEW OF THE ORIGINAL MANUFACTURING RECORDS SHOWS NO ABNORMALITIES. WITH THE INFORMATION AVAILABLE, THE SOURCE OF THE ENDOCARDITIS IS UNKNOWN. HOWEVER, BECAUSE THE COMPLICATION OCCURRED OVER TWO YEARS POST-IMPLANT AND BECAUSE THE ON-X VALVE MANUFACTURING PROCESS INCLUDES VALIDATED TERMINAL STERILIZATION ¿ VERIFIED BY A REVIEW OF MANUFACTURING RECORDS UNIQUE TO THE VALVE ¿ THE VALVE IS UNLIKELY TO BE THE SOURCE OF INFECTION. THE INSTRUCTIONS FOR USE FOR THE ON-X VALVE LISTS ENDOCARDITIS AS A POSSIBLE COMPLICATION OF MECHANICAL HEART VALVE REPLACEMENT AND INCLUDES THE POSSIBILITY OF REOPERATION AND/OR EXPLANTATION [IFU]. HISTORICALLY, ENDOCARDITIS OCCURS AT A RATE OF 0.3 %/PATIENT-YEAR FOR RIGID HEART VALVES [ISO 5840-2:2021]. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REVIEWED AND A NEED FOR INVESTIGATION WILL BE DETERMINED THEN. THE ON-X HEART VALVE RISK MANAGEMENT FILE THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR INDICATION. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS LOW AS POSSIBLE BY DESIGN AND PROCESS. POST PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT¿S LABELING AND IFU. A DEFINITIVE CAUSE FOR THE ENDOCARDITIS CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. HOWEVER, INFECTION RESULTING FROM THE ON-X VALVE IS UNLIKELY AS THE VALVE IS TERMINALLY STERILIZED PRIOR TO DISTRIBUTION. 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. 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 A SECOND MITRAL IMPLANT FOR THIS PATIENT. SN (B)(4). ONLY TOP HALF OF IRC WAS RECEIVED, SO SURGEON IS UNKNOWN."

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY: 1. VALVE WAS EXPLANTED ON (B)(6) 2022 DUE TO NEW VEGETATION PRESENT ON THE VALVE BY TEE AS WELL AS POSITIVE BLOOD CULTURES 2. WE DO NOT RETURN EXPLANTED VALVES, THESE ARE SENT TO OUR PATHOLOGY DEPARTMENT FOR REVIEW 3. ORIGINAL VALVE WAS IMPLANTED DUE TO INITIAL FINDINGS OF SEVERE MITRAL VALVE REGURGITATION AS WELL AS PRESENCE OF VEGETATION AND A POSITIVE BLOOD CULTURE BACK IN 2019. 4. OPERATIVE REPORTS ARE NOT ABLE TO BE FORWARDED. BLOOD CULTURE RESULTS WERE NOT AVAILABLE. NO ADDITIONAL INFORMATION IS FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287758 ONX MITRAL CONFORM 25/33 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXMC-25/33 00851788001303

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Other| L