BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X VALVE UNKNOWN CONFIGURATION

    MDR report key: 20614067 · Received November 5, 2024

    Report

    Report Number
    1649833-2024-00068
    Event Type
    Death
    Date Received
    November 5, 2024
    Date of Event
    May 29, 2021
    Report Date
    January 7, 2025
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITH NO RESPONSE. THE MANUFACTURING RECORDS WERE NOT REVIEWED AS SNS FOR THE DEVICES COULD NOT BE OBTAINED. THE PUBLICATION ¿LONG-TERM CLINICAL OUTCOMES OF THE ON-X MECHANICAL PROSTHETIC VALVE IN THE AORTIC OR MITRAL POSITION: A SINGLE-CENTER EXPERIENCE OF UP TO 20 YEARS¿ FOLLOW UP¿ BY KIM ET ALL PUBLISHED IN 2021 IS REVIEWED HERE. DATA FROM A RETROSPECTIVE, OBSERVATIONAL STUDY CONSISTS OF 861 PATIENTS THAT RECEIVED AN ON-X AORTIC AND/OR MITRAL VALVE IMPLANT BETWEEN 1999 AND 2015 AT SEOUL NATIONAL UNIVERSITY HOSPITAL, AVR, (N = 344), MVR (N = 325), OR DOUBLE-VALVE REPLACEMENT (N = 192). THE AIM OF THIS STUDY WAS TO EVALUATE THE LONG-TERM OUTCOMES FOR UP TO 20 YEARS AFTER ON-X BILEAFLET MECHANICAL VALVE IMPLANTATION IN THE LEFT SIDE OF THE HEART. PATIENTS WERE INCLUDED IF THEY WERE ADULTS WHO UNDERWENT PROSTHETIC VALVE REPLACEMENT USING THE ON-X VALVE IN THE AORTIC AND/OR MITRAL POSITION AND WERE EXCLUDED IF THEY UNDERWENT A SECOND VALVE REPLACEMENT WITH A NON-ON-X VALVE, HAD A TRIPLE VALVE REPLACEMENT, IF THEY UNDERWENT URGENT OR EMERGENT SURGERY. DOUBLE VALVE IMPLANTS (MVR + AVR) WERE INCLUDED. MEAN AGE OF THE PATIENTS AT OPERATION WAS 53.2 ± 11.8 FOR AORTIC 50.4 ± 10.1 FOR MITRAL AND 51.1 ± 10.3 FOR DOUBLE VALVE REPLACEMENT. WITH 36.9%% OF AORTIC, 67.1% OF MITRAL PATIENTS AND 48.4% OF DOUBLE VALVE REPLACEMENT PATIENTS BEING FEMALE. OPERATIVE MORTALITY WAS 26 (3.0%) FOR ALL PATIENTS, 9 (2.6%) FOR AVR, 12 (3.7%) FOR MVR AND 5 (2.6%) FOR DVR. OVERALL MORTALITY WAS 133 (1.6%) FOR ALL PATIENTS, 63 (2.1%) FOR AVR, 41 (1.2%) FOR MVR AND 29 (1.5%) FOR DVR. THE LOR RATES FOR THROMBOEMBOLIC EVENTS WERE 0.8% FOR AVR AND 0.7% FOR MVR AND 0.9% FOR DVR. THE RATES FOR BLEEDING EVENTS WERE 0.4% FOR AVR AND 0.8% FOR MVR AND 0.6% FOR DOUBLE. THE RATES FOR VALVE RELATED REOPERATION WERE 0.1% FOR AVR AND 0.6% FOR MVR AND 0.8% FOR DVR. THE RATES FOR PROSTHETIC VALVE ENDOCARDITIS WERE 0.1% FOR AVR, 0.1% FOR MVR AND 0.5% FOR DVR. THE RATES FOR NON-STRUCTURAL VALVE DETERIORATION WERE 0.1% FOR AVR, 0.7% FOR MVR AND 0.6% FOR DVR. WE WILL COMPARE ONLY THE AVR AND MVR RATES DIRECTLY TO THE HISTORICAL RECORD OBJECTIVE PERFORMANCE CRITERIA (OPC) [ISO 5840-2:2021(E)] AS THE RATES GIVEN IN THE OPC DO NOT INCLUDE DVR. HISTORICALLY THE THROMBOEMBOLISM (TE) OPC IS 1.6%/PT-YR FOR AVR AND 2.2 %/PT-YR FOR MVR, THE STUDY RATE WAS GIVEN AS 0.8% AVR AND 0.7% MVR. THE MAJOR BLEED OPC IS 1.6%/PT-YR FOR AORTIC AND 1.4 %/PT-YR FOR MITRAL, THE STUDY RATE WAS GIVEN AS 0.4% AVR AND 0.8% MVR. THE PROSTHETIC VALVE ENDOCARDITIS OPC IS 0.3%/PT-YR FOR AORTIC AND MITRAL, THE STUDY RATE WAS GIVEN AS 0.1% FOR BOTH AVR AND MVR. CLINICAL OUTCOMES ANALYSIS FOR A SINGLE-CENTER EXPERIENCE WITH UP TO 20 YEARS FOLLOW-UP OF ON-X PROSTHETIC HEART VALVES IN 861 PATIENTS. ADVERSE EVENT RATES ARE FAVORABLE COMPARED TO THE HISTORICAL RECORD FOR MECHANICAL PROSTHETIC VALVE REPLACEMENT FOR ALL EVENTS THAT CAN BE DIRECTLY COMPARED. MORTALITY AND ALL INDICATED COMPLICATIONS ARE RECOGNIZED IN THE VALVE¿S INSTRUCTIONS FOR USE [IFU]. 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 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 (B)(4) IS ACCURATE OR HAS BEEN CONFIRMED BY (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS RECEIVED: ¿LONG-TERM CLINICAL OUTCOMES OF THE ON-X MECHANICAL PROSTHETIC VALVE IN THE AORTIC OR MITRAL POSITION. A SINGLE-CENTER EXPERIENCE OF UP TO 20 YEARS¿ FOLLOW UP.¿ THIS PUBLICATION REPORTS 861 PATIENTS (MEAN AGE=51.6±10.9 YEARS) WHO UNDERWENT PROSTHETIC VALVE REPLACEMENT USING THE ON-X VALVE IN THE AORTIC OR MITRAL POSITION WERE ENROLLED (AORTIC=344, MITRAL=325, DOUBLE=192). THE MEAN CLINICAL FOLLOW-UP DURATION WAS 10.5±5.3 (MEDIAN 10.9) YEARS. OPERATIVE MORTALITY OCCURRED IN 26 PATIENTS (3.0%), AND LINEARIZED LATE CARDIAC MORTALITY WAS 0.9%/PATIENT-YEAR WITHOUT AN INTERGROUP DIFFERENCE. LINEARIZED THROMBOEMBOLISM, BLEEDING, PROSTHETIC VALVE ENDOCARDITIS, NON-STRUCTURAL VALVE DETERIORATION (NSVD), AND REOPERATION RATES WERE 0.8%/PATIENT-YEAR, 0.6%/PATIENT-YEAR, 0.2%/PATIENT-YEAR, 0.5%/PATIENT-YEAR, AND 0.5%/PATIENT-YEAR, RESPECTIVELY. PROSTHETIC VALVE ENDOCARDITIS WAS MORE FREQUENT AFTER DOUBLE VALVE REPLACEMENT THAN AFTER AORTIC OR MITRAL VALVE REPLACEMENT (P=0.008 AND 0.005, RESPECTIVELY). NSVD AND REOPERATION RATES WERE SIGNIFICANTLY LOWER AORTIC VALVE REPLACEMENT THAN AFTER MITRAL OR DOUBLE VALVE REPLACEMENT (P=0.001 AND 0.002, P=0.001 AND <0.001, RESPECTIVELY). VALVE REPLACEMENT IN THE MITRAL POSITION WAS THE ONLY RISK FACTOR FOR NSVD (HAZARD RATIO [95% CONFIDENCE INTERVAL]=5.247 [1.608¿17.116], P=0.006).

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS RECEIVED: ¿LONG-TERM CLINICAL OUTCOMES OF THE ON-X MECHANICAL PROSTHETIC VALVE IN THE AORTIC OR MITRAL POSITION. A SINGLE-CENTER EXPERIENCE OF UP TO 20 YEARS¿ FOLLOW UP ¿. THIS PUBLICATION REPORTS 861 PATIENTS (MEAN AGE=51.6±10.9 YEARS) WHO UNDERWENT PROSTHETIC VALVE REPLACEMENT USING THE ON-X VALVE IN THE AORTIC OR MITRAL POSITION WERE ENROLLED (AORTIC=344, MITRAL=325, DOUBLE=192). THE MEAN CLINICAL FOLLOW-UP DURATION WAS 10.5±5.3 (MEDIAN 10.9) YEARS. OPERATIVE MORTALITY OCCURRED IN 26 PATIENTS (3.0%), AND LINEARIZED LATE CARDIAC MORTALITY WAS 0.9%/PATIENT-YEAR WITHOUT AN INTERGROUP DIFFERENCE. LINEARIZED THROMBOEMBOLISM, BLEEDING, PROSTHETIC VALVE ENDOCARDITIS, NON-STRUCTURAL VALVE DETERIORATION (NSVD), AND REOPERATION RATES WERE 0.8%/PATIENT-YEAR, 0.6%/PATIENT-YEAR, 0.2%/PATIENT-YEAR, 0.5%/PATIENT-YEAR, AND 0.5%/PATIENT-YEAR, RESPECTIVELY. PROSTHETIC VALVE ENDOCARDITIS WAS MORE FREQUENT AFTER DOUBLE VALVE REPLACEMENT THAN AFTER AORTIC OR MITRAL VALVE REPLACEMENT (P=0.008 AND 0.005, RESPECTIVELY). NSVD AND REOPERATION RATES WERE SIGNIFICANTLY LOWER AORTIC VALVE REPLACEMENT THAN AFTER MITRAL OR DOUBLE VALVE REPLACEMENT (P=0.001 AND 0.002, P=0.001 AND <0.001, RESPECTIVELY). VALVE REPLACEMENT IN THE MITRAL POSITION WAS THE ONLY RISK FACTOR FOR NSVD (HAZARD RATIO [95% CONFIDENCE INTERVAL]=5.247 [1.608¿17.116], P=0.006).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405250 ON-X VALVE UNKNOWN CONFIGURATION HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC ONX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| L| R| H