BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X VALVE UNKNOWN CONFIGURATION

    MDR report key: 20613217 · Received November 5, 2024

    Report

    Report Number
    1649833-2024-00067
    Event Type
    Death
    Date Received
    November 5, 2024
    Date of Event
    May 24, 2010
    Report Date
    January 6, 2025
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 SERIAL NUMBERS FOR THE DEVICES COULD NOT BE OBTAINED. THE PUBLICATION ¿INFLUENCE OF THE ON-X MECHANICAL PROSTHESIS ON INTERMEDIATE-TERM MAJOR THROMBOEMBOLISM AND HEMORRHAGE: A PROSPECTIVE MULTICENTER STUDY¿ PUBLISHED IN 2010 IS REVIEWED HERE. DATA FROM A PROSPECTIVE, OBSERVATIONAL, MULTICENTER STUDY CONSISTS OF 737 PATIENTS THAT RECEIVED AN ON-X AORTIC AND/OR MITRAL VALVE IMPLANT BETWEEN 2003 AND 2008 AT EITHER THE UNIVERSITY OF OTTAWA OR THE UNIVERSITY OF BRITISH COLUMBIA, AVR, (N = 400), MVR (N = 282), OR DOUBLE-VALVE REPLACEMENT (N = 55). THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE PERFORMANCE OF THE ON-X MECHANICAL PROSTHESIS IN REGARD TO (1) MAJOR THROMBOEMBOLISM, (2) HEMORRHAGE, AND (3) COMPOSITES OF VALVE-RELATED COMPLICATIONS. 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 THERE WERE NO EXCLUSION CRITERIA PROVIDED. DOUBLE VALVE IMPLANTS (MVR + AVR ) WERE INCLUDED. MEAN AGE OF THE PATIENTS AT OPERATION WAS 55.2 ± 10.6 FOR AORTIC AND 58.7 ± 10.7 FOR MITRAL WITH 27% OF AORTIC AND 64% OF MITRAL PATIENTS BEING FEMALE. THE LOR RATES FOR MAJOR THROMBOEMBOLISM WERE 0.94% FOR AORTIC AND 0.72% FOR MITRAL, THE RATES FOR HEMORRHAGE WERE 1.60% FOR AORTIC AND 1.20 FOR MITRAL, THE RATES FOR VALVE RELATED REOPERATION WERE 0.38% FOR AORTIC AND 0.24% FOR MITRAL AND THE RATES FOR VALVE RELATED MORTALITY WERE 0.19% FOR AORTIC AND 0.12%FOR MITRAL. WE ARE UNABLE TO COMPARE DIRECTLY TO THE HISTORICAL RECORD OBJECTIVE PERFORMANCE CRITERIA (OPC) [ISO 5840-2:2021(E)] AS THE RATES GIVEN ARE FOR ALL PROCEDURES INCLUDING DOUBLE VALVE REPLACEMENTS. HISTORICALLY THE THROMBOEMBOLISM (TE) OPC IS 1.6%/PT-YR FOR AORTIC AND 2.2 %/PT-YR FOR MITRAL, THE STUDY RATE WAS GIVEN AS 0.94%. AND 0.72%. THE MAJOR BLEED OPC IS 1.6%/PT-YR FOR AORTIC AND 1.4 %/PT-YR FOR MITRAL, THE STUDY RATE WAS GIVEN AS 1.6% AND 1.2%. MORTALITY AND ALL INDICATED COMPLICATIONS ARE RECOGNIZED IN THE VALVE¿S INSTRUCTIONS FOR USE [IFU]. ACCORDING TO THE AUTHORS THE ON-X MECHANICAL PROSTHESIS PROVIDES FAVORABLE INTERMEDIATE-TERM RESULTS WITH REGARD TO MAJOR THROMBOEMBOLISM, HEMORRHAGE, AND COMPOSITES OF VALVE-RELATED COMPLICATIONS. CLINICAL OUTCOMES ANALYSIS FOR A MULTI-CENTER EXPERIENCE WITH UP TO 2.8 ± 0.7 YEARS FOLLOW-UP OF ON-X PROSTHETIC HEART VALVES IN 737 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 ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS RECEIVED: ¿INFLUENCE OF THE ON-X MECHANICAL PROSTHESIS ON INTERMEDIATE-TERM MAJOR THROMBOEMBOLISM AND HEMORRHAGE: A PROSPECTIVE MULTICENTER STUDY.¿ THIS PUBLICATION REPORTS ON 737 PATIENTS THAT UNDERWENT EITHER AORTIC, MITRAL OR DOUBLE VALVE REPLACEMENT BETWEEN 2003 AND 2008. THE RESULTS ARE: EARLY MORTALITY WAS 2.5% (N = 10) FOR AORTIC VALVE REPLACEMENT AND 3.2% (N = 9) FOR MITRAL VALVE REPLACEMENT. LATE MORTALITY FOR AORTIC VALVE REPLACEMENT WAS 4.8% PER PATIENT-YEAR AND 6.0% PER PATIENT-YEAR FOR MITRAL VALVE REPLACEMENT. FIVE-YEAR FREEDOM FROM MAJOR THROMBOEMBOLISM WAS 96.5% ± 1.2% FOR AORTIC VALVE REPLACEMENT AND 97.7% ± 0.9% FOR MITRAL VALVE REPLACEMENT. FIVE-YEAR FREEDOM FROM HEMORRHAGE WAS 93.6% ± 1.8% FOR AORTIC VALVE REPLACEMENT AND 95.7% ± 1.5% FOR MITRAL VALVE REPLACEMENT. CONCOMITANT CORONARY ARTERY BYPASS GRAFTING WAS PREDICTIVE OF MAJOR THROMBOEMBOLISM AFTER AORTIC VALVE REPLACEMENT (HAZARD RATIO, 5.3; P = .02) AND ANTITHROMBOTIC HEMORRHAGE AFTER MITRAL VALVE REPLACEMENT (HAZARD RATIO, 4.7; P =.03). NO OTHER INDEPENDENT PREDICTORS OF MAJOR THROMBOEMBOLISM OR HEMORRHAGE WERE IDENTIFIED. ONE THROMBOSED MITRAL PROSTHESIS WAS OBSERVED AFTER DELIBERATE DISCONTINUATION OF ANTICOAGULATION. THE MAJOR THROMBOEMBOLIC EVENTS OCCURRED WITH VARIATION OF INTERNATIONAL NORMALIZED RATIO LEVELS INCLUSIVE OF SUBTHERAPEUTIC LEVELS. THE MAJORITY OF HEMORRHAGIC EVENTS OCCURRED WITH HIGH INTERNATIONAL NORMALIZED RATIO LEVELS.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS RECEIVED: ¿INFLUENCE OF THE ON-X MECHANICAL PROSTHESIS ON INTERMEDIATE-TERM MAJOR THROMBOEMBOLISM AND HEMORRHAGE: A PROSPECTIVE MULTICENTER STUDY¿. THIS PUBLICATION REPORTS ON 737 PATIENTS THAT UNDERWENT EITHER AORTIC, MITRAL OR DOUBLE VALVE REPLACEMENT BETWEEN 2003 AND 2008. THE RESULTS ARE: EARLY MORTALITY WAS 2.5% (N = 10) FOR AORTIC VALVE REPLACEMENT AND 3.2% (N = 9) FOR MITRAL VALVE REPLACEMENT. LATE MORTALITY FOR AORTIC VALVE REPLACEMENT WAS 4.8% PER PATIENT-YEAR AND 6.0% PER PATIENT-YEAR FOR MITRAL VALVE REPLACEMENT. FIVE-YEAR FREEDOM FROM MAJOR THROMBOEMBOLISM WAS 96.5% ± 1.2%FOR AORTIC VALVE REPLACEMENT AND 97.7% ± 0.9%FOR MITRAL VALVE REPLACEMENT. FIVE-YEAR FREEDOM FROM HEMORRHAGE WAS 93.6% ± 1.8%FOR AORTIC VALVE REPLACEMENT AND 95.7% ± 1.5%FOR MITRAL VALVE REPLACEMENT. CONCOMITANT CORONARY ARTERY BYPASS GRAFTING WAS PREDICTIVE OF MAJOR THROMBOEMBOLISM AFTER AORTIC VALVE REPLACEMENT (HAZARD RATIO, 5.3; P = .02) AND ANTITHROMBOTIC HEMORRHAGE AFTER MITRAL VALVE REPLACEMENT (HAZARD RATIO, 4.7; P =.03). NO OTHER INDEPENDENT PREDICTORS OF MAJOR THROMBOEMBOLISM OR HEMORRHAGE WERE IDENTIFIED. ONE THROMBOSED MITRAL PROSTHESIS WAS OBSERVED AFTER DELIBERATE DISCONTINUATION OF ANTICOAGULATION. THE MAJOR THROMBOEMBOLIC EVENTS OCCURRED WITH VARIATION OF INTERNATIONAL NORMALIZED RATIO LEVELS INCLUSIVE OF SUBTHERAPEUTIC LEVELS. THE MAJORITY OF HEMORRHAGIC EVENTS OCCURRED WITH HIGH INTERNATIONAL NORMALIZED RATIO LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860247 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 Hospitalization| D| L