ON-X VALVE UNKNOWN
Report
- Report Number
- 1649833-2024-00052
- Event Type
- Death
- Date Received
- October 24, 2024
- Report Date
- January 9, 2025
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- PMA / PMN Number
- P000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED AS DEFINITIVE SERIAL NUMBERS AND DATE OF SURGERIES WERE NOT PROVIDED BY THE COMPLAINANT. THE PUBLICATION ¿SINGLE-CENTER EXPERIENCE WITH THE ON-X PROSTHETIC HEART VALVE BETWEEN 1996 AND 2005¿ BY TOSSIOS ET ALL PUBLISHED IN 2007 IS REVIEWED HERE. DATA FROM A RETROSPECTIVE SINGLE-CENTER STUDY CONSISTS OF 459 PATIENTS THAT RECEIVED AN ON-X AORTIC AND/OR MITRAL VALVE IMPLANT BETWEEN 1996 AND 1999 AT 11 EUROPEAN CENTERS, AVR, (N = 264), MVR (N = 164) AND DVR (N=31). THE SUBGROUP OF PATIENTS THAT RECEIVED A DVR WERE EXCLUDED FROM THE STUDY AS NOT ALL SUBJECTS RECEIVED BOTH AN ON-X AORTIC AND MITRAL VALVE, SO ONLY 428 PATIENTS WERE INCLUDED IN THE STUDY. THE AIM OF THIS STUDY WAS TO EVALUATE THE REAL IMPACT OF THE ON-X VALVE IN HEART VALVE SURGERY IN A SINGLE -CENTER INSTITUTION WITH A CLINICAL EXPERIENCE OF ALMOST 10 YEARS. PATIENTS WERE INCLUDED IF THEY WERE ADULTS WHO UNDERWENT PROSTHETIC VALVE REPLACEMENT USING THE ON-X VALVE IN THE AORTIC OR MITRAL POSITION, NO EXCLUSION CRITERIA WERE LISTED. MEAN AGE OF THE PATIENTS AT OPERATION WAS 62 ± 9 FOR AORTIC 64 ± 11 FOR MITRAL, WITH 29% OF AORTIC, 59% OF MITRAL PATIENTS BEING FEMALE. EARLY OVERALL MORTALITY WAS 10 (3.7%) FOR AVR AND 23 (14%) FOR MVR AND VALVE RELATED EARLY MORTALITY WAS 1 (0.4%) FOR AVR AND 2 (1.2%) FOR MVR. LATE OVERALL MORTALITY WAS 42 (3.92%) FOR AVR AND 33 (5.92%) FOR MVR AND VALVE RELATED LATE MORTALITY WAS 19 (1.77%) FOR AVR AND 12 (2.15%) FOR MVR. THE LOR RATES FOR THROMBOEMBOLISM WERE 1.49% FOR AVR AND 1.61% FOR MVR, THERE WAS 2 (0.35%) REPORTED CASES OF THROMBOSIS FOR MVR. THE RATES FOR HEMORRHAGE EVENTS WERE 0.93% FOR AVR AND 1.43% FOR MVR. THE RATES FOR PROSTHETIC VALVE ENDOCARDITIS WERE 0.37% FOR AVR, 0.17% FOR MVR . THE RATES FOR NON-STRUCTURAL FAILURE WERE 0.18% FOR AVR AND 1.43% FOR MVR AND THERE WERE NO CASES OF STRUCTURAL FAILURE. THE RATES FOR REOPERATION WERE 0.28% FOR AVR AND 0.71% FOR MVR. WE COMPARED THE AVR AND MVR RATES DIRECTLY TO THE HISTORICAL RECORD OBJECTIVE PERFORMANCE CRITERIA (OPC) [ISO 5840-2:2021(E)]. 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 1.49% AVR AND 1.61% 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 0.93% AVR AND 1.43% MVR. THE PROSTHETIC VALVE ENDOCARDITIS OPC IS 0.3%/PT-YR FOR AORTIC AND MITRAL, THE STUDY RATE WAS GIVEN AS 0.37% FOR AVR AND 0.17 % MVR. MORTALITY AND ALL INDICATED COMPLICATIONS ARE RECOGNIZED IN THE VALVE¿S INSTRUCTIONS FOR USE [IFU]. ACCORDING TO THE AUTHORS THE ON-X HEART VALVE MAY BE CONSIDERED SAFE AND RELIABLE, WHILE PROVIDING SURGICAL ADVANTAGES OF SUPRA-ANNULAR IMPLANTATION. CLINICAL OUTCOMES ANALYSIS FOR A MULTI-CENTER EXPERIENCE WITH UP TO 9.3 YEARS FOLLOW-UP OF ON-X PROSTHETIC HEART VALVES IN 428 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]. THE DATA COLLECTED IS PART OF A CLINICAL STUDY; THUS, SEVERITY AND OCCURRENCE IS NOT EVALUATED. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THESE EVENTS CANNOT BE DETERMINED. 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]. THESE EVENTS DO 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.
THE PUBLICATION TITLED, ¿SINGLE-CENTER EXPERIENCE WITH THE ON-X PROSTHETIC HEART VALVE BETWEEN 1996 AND 2005¿ AND A REQUEST WAS MADE TO FIELD ASSURANCE TO DETERMINE IF THIS WAS A PREVIOUSLY REPORTED PUBLICATION. IT WAS DETERMINED THAT THIS PAPER HAD NOT BEEN REPORTED THROUGH FIELD ASSURANCE. THIS PUBLICATION REPORTS ON 428 PATIENTS (255 MALES, 173 FEMALES; MEAN AGE 62.7 YEARS) WHO UNDERWENT EITHER AORTIC VALVE REPLACEMENT (AVR; N = 264) OR MITRAL VALVE REPLACEMENT (MVR; N = 164) USING THE ON-X PROSTHESIS AT UNIVERSITY OF BOCHUM STARTING IN SEPTEMBER 1996. THE MEAN FOLLOW UP WAS 3.9 YEARS, AND CUMULATIVE FOLLOW UP 1,625 PATIENT-YEARS (PT-YR); THE OVERALL FOLLOW UP RATE WAS 98.7%. RESULTS: EARLY MORTALITY (=30 DAYS) WAS 3.7% AFTER AVR AND 14.0% AFTER MVR, WITH VALVE-RELATED MORTALITY RATES OF 0.4% AND 1.2%, RESPECTIVELY. AT AUTOPSY (N = 12) ALL IMPLANTS WERE INTACT. FREEDOM FROM VALVE RELATED DEATH AT NINE YEARS WAS 85.0 ± 3.9% AFTER AVR AND 87.6 ± 3.2% AFTER MVR. THE OVERALL SURVIVAL RATE WAS 67.9 ± 4.3% AFTER AVR AND 52.7 ± 8.1% AFTER MVR. THE LINEARIZED RATE OF THROMBOEMBOLISM FOR AVR AND MVR WAS 1.49%/PT-YR AND 1.61%/PT-YR; OF THROMBOSIS 0%/PT-YR AND 0.35%/PT-YR; OF HEMORRHAGE 0.93%/PT-YR AND 1.43%/PT-YR; OF ENDOCARDITIS 0.37%/PT-YR AND 0.17%/PT-YR; OF NON-STRUCTURAL FAILURE 0.18%/PT-YR AND 1.43%/PT-YR; AND OF REOPERATION 0.28%/PT-YR AND 0.53%/PT-YR. THERE WERE NO CASES OF STRUCTURAL VALVE FAILURE. CONCLUSION: AFTER ALMOST ONE DECADE OF CLINICAL EXPERIENCE IN A SINGLE CENTER, THE ON-X HEART VALVE CONTINUES TO BE RELIABLE AND EFFECTIVE.
THE PUBLICATION TITLED, ¿SINGLE-CENTER EXPERIENCE WITH THE ON-X PROSTHETIC HEART VALVE BETWEEN 1996 AND 2005¿ AND A REQUEST WAS MADE TO FIELD ASSURANCE TO DETERMINE IF THIS WAS A PREVIOUSLY REPORTED PUBLICATION. IT WAS DETERMINED THAT THIS PAPER HAD NOT BEEN REPORTED THROUGH FIELD ASSURANCE. THIS PUBLICATION REPORTS ON 428 PATIENTS (255 MALES, 173 FEMALES; MEAN AGE 62.7 YEARS) WHO UNDERWENT EITHER AORTIC VALVE REPLACEMENT (AVR; N = 264) OR MITRAL VALVE REPLACEMENT (MVR; N = 164) USING THE ON-X PROSTHESIS AT UNIVERSITY OF BOCHUM STARTING IN SEPTEMBER 1996. THE MEAN FOLLOW UP WAS 3.9 YEARS, AND CUMULATIVE FOLLOW UP 1,625 PATIENT-YEARS (PT-YR); THE OVERALL FOLLOW UP RATE WAS 98.7%. RESULTS: EARLY MORTALITY (=30 DAYS) WAS 3.7% AFTER AVR AND 14.0% AFTER MVR, WITH VALVE-RELATED MORTALITY RATES OF 0.4% AND 1.2%, RESPECTIVELY. AT AUTOPSY (N = 12) ALL IMPLANTS WERE INTACT. FREEDOM FROM VALVE RELATED DEATH AT NINE YEARS WAS 85.0 ± 3.9% AFTER AVR AND 87.6 ± 3.2% AFTER MVR. THE OVERALL SURVIVAL RATE WAS 67.9 ± 4.3% AFTER AVR AND 52.7 ± 8.1% AFTER MVR. THE LINEARIZED RATE OF THROMBOEMBOLISM FOR AVR AND MVR WAS 1.49%/PT-YR AND 1.61%/PT-YR; OF THROMBOSIS 0%/PT-YR AND 0.35%/PT-YR; OF HEMORRHAGE 0.93%/PT-YR AND 1.43%/PT-YR; OF ENDOCARDITIS 0.37%/PT-YR AND 0.17%/PT-YR; OF NON-STRUCTURAL FAILURE 0.18%/PT-YR AND 1.43%/PT-YR; AND OF REOPERATION 0.28%/PT-YR AND 0.53%/PT-YR. THERE WERE NO CASES OF STRUCTURAL VALVE FAILURE. CONCLUSION: AFTER ALMOST ONE DECADE OF CLINICAL EXPERIENCE IN A SINGLE CENTER, THE ON-X HEART VALVE CONTINUES TO BE RELIABLE AND EFFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1856848 | ON-X VALVE UNKNOWN | HEART-VALVE, MECHANICAL | LWQ | ON-X LIFE TECHNOLOGIES, INC. | ONX UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |