BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX MITRAL STANDARD 27/29

    MDR report key: 16146327 · Received January 12, 2023

    Report

    Report Number
    1649833-2023-00001
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    December 12, 2022
    Report Date
    March 17, 2023
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001280
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS FOR THE ONXM-27/29 SERIAL NUMBER (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. ONXM-27/29 SN (B)(6) WAS IMPLANTED IN THE MITRAL POSITION ON (B)(6) 2021 IN A PATIENT OF UNKNOWN GENDER AND AGE. THIS VALVE WAS REPORTED AS EXPLANTED ON (B)(6) 2021 (192 DAYS POST-IMPLANT) DUE TO THROMBOSIS. THE EXPLANT OPERATIVE REPORT WAS MADE AVAILABLE, AND THE VALVE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE EXPLANT OPERATIVE REPORT STATES THAT THE ¿MITRAL VALVE PROSTHESIS WAS FOUND TO BE THROMBOSED. THERE WAS NO EVIDENCE OF PANNUS INGROWTHS¿. THE RETURNED EXPLANTED VALVE WAS EXAMINED. AS RECEIVED, A LARGE TISSUE OBSTRUCTION CAN BE SEEN ON BOTH THE OUTFLOW AND INFLOW SIDES OF THE VALVE. THIS THROMBUS INTERFERED WITH THE NORMAL OPERATION OF THE LEAFLETS, AND THEY WOULD NOT ARTICULATE. PRIOR TO DECONTAMINATION A VISUAL EXAMINATION OF THE VALVE SHOWS THE LEAFLET AND HOUSING INTACT, AND NO ABNORMALITIES OBSERVED WITH THE VALVE ASSEMBLY. AFTER DECONTAMINATION, THROMBUS REMAINED BUT WAS REDUCED THE VALVE WAS VISUALLY EXAMINED AND NO DEFICIENCIES WERE NOTED. THERE WAS NO EVIDENCE OF PANNUS FORMATION. THE VALVE FAILURE WAS CONFIRMED TO BE DUE TO THROMBOSIS AND THERE WAS NO SIGN OF A DEFECT WITH THE VALVE. WITHOUT ANY LAB DATA SUCH AS INR OR COAGULOPATHY RESULTS AVAILABLE FOR REVIEW, WE ARE UNABLE TO ARRIVE AT A CONCLUSIVE ROOT CAUSE, HOWEVER THE MOST COMMON CAUSE OF VALVE THROMBUS IN THIS SITUATION IS INADEQUATE ANTICOAGULATION. THROMBUS IS A RARE, BUT A KNOWN POTENTIAL COMPLICATION OF PROSTHETIC VALVE REPLACEMENT OCCURRING AT A HISTORICAL RATE OF (B)(4) PER PATIENT-YEAR FOR MECHANICAL MITRAL HEART VALVES [ISO 5840-2:2021 (E)]. IT IS RECOGNIZED AS A POTENTIAL ADVERSE EVENT FOR THE ON-X VALVE ALONG WITH THE POTENTIAL FOR REOPERATION AND EXPLANTATION [IFU]. THE DEFINITIVE ROOT CAUSE OF THE THROMBOSIS IS UNKNOWN CONSIDERING THE LIMITED LAB RESULTS. HOWEVER, THE MOST COMMON CASE OF VALVE THROMBOSIS IN THIS SITUATION IS INADEQUATE ANTICOAGULATION AND THIS CAN LEAD TO THE NEED FOR EXPLANT AND REPLACEMENT OF THE MECHANICAL HEART VALVE. 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

    THIS IS A CORRECTION REPORT FOR THE FOLLOWING STATEMENT: THE DEFINITIVE ROOT CAUSE OF THE THROMBOSIS IS UNKNOWN CONSIDERING THE LIMITED LAB RESULTS. HOWEVER, THE MOST COMMON CAUSE OF VALVE THROMBOSIS IN THIS SITUATION IS INADEQUATE ANTICOAGULATION AND THIS CAN LEAD TO THE NEED FOR EXPLANT AND REPLACEMENT OF THE MECHANICAL HEART VALVE.

    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.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, THIS ONXM-27/29 SN (B)(6) WAS IMPLANTED ON (B)(6) 2021 IN WHICH A REDO PROCEDURE WAS PERFORMED.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, THIS ONXM-27/29 SN (B)(4) WAS IMPLANTED ON (B)(6) 2021 IN WHICH A REDO PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573940 ONX MITRAL STANDARD 27/29 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXM-27/29 00851788001280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R