ON-X VALVE UNKNOWN CONFIGURATION
Report
- Report Number
- 1649833-2024-00057
- Event Type
- Death
- Date Received
- October 31, 2024
- Report Date
- January 2, 2025
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- PMA / PMN Number
- P000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ACCORDING TO PUBLICATION, "EARLY CLINICAL EXPERIENCE WITH THE ON-X PROSTHETIC HEART VALVE" UMIT O¨ ZYURDAA, A. RUCHAN AKARA,*, OZGE UYMAZA, MEHMET OGUZB, MEHMET OZKANB, CELIL YILDIRIMB, ALP ASLANB, REFIK TASOZA, THIS PUBLICATION REPORTS ON 400 PATIENTS AGED 19¿85 YEARS (MEAN: 55.6 ± 16), 290 MALES AND 210 FEMALES IMPLANTED BETWEEN DECEMBER 2000 AND JANUARY 2003. THERE WERE 120 CASES OF AORTIC VALVE REPLACEMENT (AVR), 258 MITRAL VALVE REPLACEMENT (MVR) AND 22 COMBINED AORTIC AND MITRAL VALVE REPLACEMENT (DVR). ADDITIONAL PROCEDURES WERE PERFORMED IN 144 PATIENTS. PATIENTS WERE FOLLOWED UP PROSPECTIVELY AT 3- TO 6-MONTH INTERVALS. MEAN FOLLOW-UP WAS 38.4 ± 11.8 MONTHS (MAXIMUM 55.6 MONTHS). OVERALL HOSPITAL MORTALITY WAS 3.5%. FREEDOM FROM ADVERSE EVENTS AT 4 YEARS IN THE STUDY WERE AS FOLLOWS: THROMBOEMBOLISM, 99.1% FOR AVR, 98.3% FOR MVR AND 94.7% FOR DVR PATIENTS; THROMBOSIS, 100% FOR AVR, 99.2% FOR MVR AND 94.7% FOR DVR; BLEEDING EVENTS, 99.1% FOR AVR, 99.2% FOR MVR AND 88.8% FOR DVR; PROSTHETIC ENDOCARDITIS, 98.2% FOR AVR, 99.2% FOR MVR AND 94.7% FOR DVR. OVERALL SURVIVAL AT 4 YEARS WAS 92 ± 1%. AT ECHOCARDIOGRAPHICAL EXAMINATION WITHIN 1 YEAR OF THE AVR, THE MEAN AORTIC VALVE GRADIENT WAS 12.8±6, 10.3±3, 9.0±4, 8.3±3, AND 6.2±3 MMHG FOR 19, 21, 23, 25, 27Y29 MM VALVE SIZES, RESPECTIVELY. MVR MEAN GRADIENT WAS 4.9±2, 4.5±1.2 AND 4.0±0.8 MMHG FOR 25, 27Y29, 31Y33 MM VALVE SIZES. CONCLUSION: THIS STUDY DEMONSTRATED THE EARLY CLINICAL AND HEMODYNAMIC PERFORMANCE OF THE ON-X MECHANICAL BILEAFLET PROSTHESIS IN THE AORTIC AND MITRAL POSITIONS TO BE SATISFACTORY WITH AN ACCEPTABLE EARLY MORTALITY AND MORBIDITY. THIS INVESTIGATION IS RELEGATED TO ONX OF UNKNOWN CONFIGURATION FOR 59 EVENTS: THROMBOEMBOLISM ¿ 6, THROMBOSIS ¿ 3, PROSTHETIC VALVE ENDOCARDITIS 6, NON-STRUCTURAL VALVE DETERIORATION (PARAVALVULAR LEAKS) ¿ 4, RE-OPERATION ¿ 12, CARDIAC FAILURE ¿ 4, ISCHEMIA ¿ 4, HEMORRHAGE ¿ 6, MORTALITY ¿ 14. NO SPECIFIC PRODUCT IDENTIFYING INFORMATION IS KNOWN. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE GONE UNMET. NO ADDITIONAL INFORMATION IS FORTHCOMING. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED AS A DEFINITIVE SERIAL NUMBER AND DATE OF SURGERY WERE NOT PROVIDED BY THE COMPLAINANT. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE PUBLICATION¿ EARLY CLINICAL EXPERIENCE WITH THE ON-X PROSTHETIC HEART VALVE¿ BY OZYURDA ET ALL PUBLISHED IN 2005 IS REVIEWED HERE. DATA CONSISTS OF 400 PATIENTS FROM A RETROSPECTIVE, OBSERVATIONAL SURVEY AT THE UNIVERSITY OF ANKARA. IMPLANTS OCCURRED BETWEEN DECEMBER 2000 TO JANUARY 2003 USING THE ON-X VALVE IN THE AORTIC AND/OR MITRAL POSITION (AORTIC=120, MITRAL=258, DUAL=22). 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 DID NOT MEET AN EXCLUSION CRITERION. OUTCOMES OF AORTIC AND MITRAL VALVE REPLACEMENT WITH THE ON-X VALVE WERE EVALUATED TO INCLUDE EARLY CLINICAL AND HEMODYNAMIC PERFORMANCE. IN THE AVR GROUP 65% OF PATIENTS WERE MALE, IN THE MVR GROUP 39% WERE MALE, AND IN THE DVR GROUP 54.5% WERE MALE. THE MEAN AGE AT IMPLANT WAS 56.2 ± 13 YEARS IN AVR PATIENTS, 55.1 ± 16 YEARS IN MVR AND 54.7 ± 9 IN THE DVR GROUP. FOLLOW-UP ECHOCARDIOGRAMS WERE OBTAINED BEFORE DISCHARGE, AT 6 MONTHS POSTOPERATIVELY AND ANNUALLY THEREAFTER. OVERALL OPERATIVE MORTALITY WAS 3.5% (14 PATIENTS). THE OPERATIVE DEATHS WERE 5 (4.2%) IN THE AVR COHORT, 8 (3.1%) IN THE MVR COHORT AND 1 (4.5%) IN THE DVR COHORT. OPERATIVE MORTALITY WAS 3.6% FOR ISOLATED AVR, 2.6% FOR ISOLATED MVR, AND 4.5% FOR DVR, 5.5% FOR AVR AND CABG, 6.9% FOR MVR AND CABG. CAUSES OF DEATH WERE CARDIAC FAILURE (4), MYOCARDIAL INFARCTION (1), VENTRICULAR ARRHYTHMIAS (3), ENDOCARDITIS (1), STROKE (1), SEPSIS (1), MULTIPLE ORGAN FAILURE (1), ANTICOAGULANT RELATED HEMORRHAGE (1), MESENTERIC ISCHEMIA (1). FOUR OF THE 14 OPERATIVE DEATHS OCCURRED IN PATIENTS WHO WERE IN CARDIOGENIC SHOCK PREOPERATIVELY. EARLY TOTAL VALVE-RELATED ADVERSE EVENTS WERE 1.66% FOR AVR, 1.93% FOR MVR AND 9.09% FOR DVR. EARLY VALVE-RELATED MORTALITY WAS 0% FOR AVR AND 0.38% FOR MVR. THERE HAVE BEEN 15 LATE DEATHS AT 4 YEARS. THE LATE DEATHS WERE 3 (2.6%) IN THE AVR COHORT, 10 (4.0%) IN THE MVR COHORT AND 2 (9.5%) IN THE DVR COHORT. A PROSTHESIS RELATED DEATH OCCURRED IN FIVE PATIENTS AS A RESULT OF ENDOCARDITIS (3), THROMBOSIS (1), INTRACRANIAL HEMORRHAGE (1). FOUR PATIENTS DIED FROM CARDIAC FAILURE AND/OR ISCHEMIA; THREE OF THEM HAD CABG AT THE TIME OF VALVE REPLACEMENT AND ONE HAD NON-GRAFTABLE DISEASED CORONARY ARTERIES. THERE WERE SIX NON-VALVE-RELATED DEATHS, FROM TRAUMA, LUNG CANCER, PNEUMONIA, EMPHYSEMA AND A ROAD TRAFFIC ACCIDENT. KAPLAN¿MEIER OVERALL SURVIVAL AT 4 YEARS WAS 92±1%. THERE WERE SIX THROMBOEMBOLIC EPISODES, 1 AVR, 4 MVR AND 1 DVR, TWO MAJOR AND FOUR MINOR. THE LINEARIZED RATE FOR THE OCCURRENCE OF THROMBOEMBOLISM WAS 0.12% PATIENT-YEAR AFTER AVR AND 0.3% PATIENT-YEAR AFTER MVR. THERE WAS NO EARLY THROMBOSED VALVE IN THIS SERIES. HOWEVER, THREE LATE THROMBOTIC EPISODES OCCURRED 9, 17, 24 MONTHS POSTOPERATIVELY (2 MVR AND 1 DVR). INR LEVELS WERE BELOW 1.4 IN ALL PATIENTS WHO PRESENTED WITH VALVE THROMBOSIS. THE LINEARIZED RATE OF VALVE THROMBOSIS WAS 0% PATIENT-YEAR AFTER AVR AND 0.35% PATIENT-YEAR AFTER MVR. SIX EPISODES WERE REPORTED: 1 AVR, 3 MVR, 2 DVR. EARLY BLEEDING EVENTS OCCURRED IN 2 MVR PATIENTS (0.77%) AND ONE DVR PATIENT (4.5%). THE LINEARIZED RATE OF ANTICOAGULANT-RELATED HEMORRHAGE WAS 0.2% PATIENT-YEAR AFTER AVR AND 0.75% PATIENT-YEAR AFTER MVR. SIX EPISODES OF ENDOCARDITIS OCCURRED 6, 8, 12, 22, 29 AND 35 MONTHS POSTOPERATIVELY ON AN ON-X MECHANICAL VALVE RESPECTIVELY (2 AVR, 3 MVR, 1 DVR). THE LINEARIZED RATE OF ENDOCARDITIS IN PATIENTS WHO HAD UNDERGONE AVR AND MVR WAS 0.35% AND 0.25% PATIENT-YEAR, RESPECTIVELY. THERE WERE NO CASES OF STRUCTURAL OR MECHANICAL VALVE FAILURE IN THIS SERIES. NON-STRUCTURAL VALVE FAILURE IN THE FORM OF PARAVALVULAR LEAKS OCCURRED EARLY IN 4 PATIENTS (1 AVR, 0.83%; 2 MVR, 0.77%; 1 DVR 4.5%) HOWEVER, ALL DETECTED PARAVALVULAR LEAKS WERE MINOR AND NOT TREATED SURGICALLY. SEVEN PATIENTS WERE REOPERATED: AVR 1, MVR 4, DVR 2. INFECTIVE ENDOCARDITIS (5) AND THROMBOSED VALVES (2) WERE THE REASONS FOR REOPERATION. KAPLAN¿MEIER FREEDOM FROM REOPERATION WAS 99.1±0.8% FOR AVR, 98.7±0.7% FOR MVR AND 88.9±7.4% FOR DVR AT 4 YEARS. OVERALL FREEDOM FROM REOPERATION AT 4 YEARS WAS 98.4±0.6%. COMPARING DIRECTLY TO THE HISTORICAL RECORD OBJECTIVE PERFORMANCE CRITERIA (OPC) [ISO 5840-2:2021(E)], AORTIC THROMBOEMBOLISM (TE) OCCURRED AT A RATE OF 0.12%/PATIENT-YEAR (PT-YR) COMPARED TO THE OPC OF 1.6%/PT-YR. FOR THE MITRAL POSITION, TE RATES WERE 0.30%/PT-YR COMPARED TO 2.2 %/PT-YR. VALVE THROMBOSIS WAS 0% PATIENT-YEAR AFTER AVR AND 0.35% PATIENT-YEAR AFTER MVR COMPARED TO THE OPC OF 0.1%/PT-YR FOR AORTIC AND 0.2%/PT-YR FOR MITRAL. HISTORICAL OPC¿S FROM THE TIME OF PUBLICATION (2005) SHOW THE VALVE THROMBOSIS RATE FOR RIGID HEART VALVE SUBSTITUTES IS 0.8%/PT-YR. AORTIC ENDOCARDITIS OCCURRED AT A RATE OF 0.35 %/PATIENT-YEAR (PT-YR) COMPARED TO THE OPC OF 0.3%/PT-YR. MITRAL ENDOCARDITIS OCCURRED AT A RATE OF 0.25%/PATIENT-YEAR (PT-YR) COMPARED TO THE OPC OF 0.3%/PT-YR. AGAIN, HISTORICAL OPC¿S FROM THE TIME OF PUBLICATION (2005) SHOW THE ENDOCARDITIS RATE FOR RIGID HEART VALVE SUBSTITUTES IS 1.2%/PATIENT-YEAR. ANTICOAGULANT-RELATED HEMORRHAGE OCCURRED AT A RATE 0.2%/PATIENT-YEARS FOR AORTIC AND AT A RATE OF 0.75%/PATIENT-YEARS FOR MITRAL, COMPARED TO THE OPC FOR MAJOR HEMORRHAGE FOR AORTIC 1.6 %/PT-YR AND MITRAL 1.4%/PT-YR. ALL PARAVALVULAR LEAKS REPORTED IN THIS PUBLICATION WERE DEEMED MINOR AND NOT TREATED SURGICALLY AND THEREFORE ARE NOT COMPARABLE TO THE OPC CATEGORY OF MAJOR PARAVALVULAR LEAK. MORTALITY AND ALL INDICATED COMPLICATIONS ARE RECOGNIZED IN THE VALVE¿S INSTRUCTIONS FOR USE [IFU]. ACCORDING TO THE AUTHORS THIS STUDY DEMONSTRATED THE EARLY CLINICAL AND HEMODYNAMIC PERFORMANCE OF THE ON-X MECHANICAL BILEAFLET PROSTHESIS IN THE AORTIC AND MITRAL POSITIONS TO BE SATISFACTORY WITH AN ACCEPTABLE EARLY MORTALITY AND MORBIDITY. THE 30-DAY MORTALITY RATE OF 3.5% WAS INDEPENDENT OF VALVE RELATED COMPLICATIONS APART FROM ONE PATIENT. THE LACK OF THROMBOSED VALVE IN THE AORTIC POSITION DESERVES ATTENTION FOR ON-X VALVES AND THE LACK OF TISSUE OVERGROWTH AND HEMOLYTIC ANEMIA IN THIS SERIES WERE ALSO GRATIFYING. FURTHERMORE, NORMAL, OR SUPRA-NORMAL VALUES OF SERUM LDH LEVELS SUGGEST THAT ON-X VALVE DESIGN MAY SUBSTANTIALLY REDUCE TURBULENCE. CLINICAL OUTCOMES ANALYSIS FOR A MULTI-CENTER EXPERIENCE WITH UP TO 5 YEARS FOLLOW-UP OF ON-X PROSTHETIC HEART VALVES IN THE AORTIC AND/OR MITRAL POSITION OF 400 PATIENTS. ADVERSE EVENT RATES ARE FAVORABLE COMPARED TO THE HISTORICAL RECORD FOR MECHANICAL PROSTHETIC VALVE REPLACEMENT. MORTALITY AND ALL INDICATED COMPLICATIONS ARE RECOGNIZED IN THE VALVE¿S INSTRUCTIONS FOR USE [IFU]. NO FURTHER ACTION IS REQUIRED. A COMPLAINT AND RECALL QUERY COULD NOT BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR THESE EVENTS CANNOT BE DETERMINED. ADDITIONALLY, ADVERSE EVENT RATES ARE FAVORABLE COMPARED TO THE HISTORICAL RECORD FOR MECHANICAL PROSTHETIC VALVE REPLACEMENT. 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 COMPLAINT WAS REVIEWED FOR A CAPA EVALUATION AND A CAPA IS NOT WARRANTED AT THIS TIME. ARTIVION WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. 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 ¿ FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC.
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 ¿ FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION ¿ FORMERLY CRYOLIFE/JOTEC.
ACCORDING PUBLICATION, "EARLY CLINICAL EXPERIENCE WITH THE ON-X PROSTHETIC HEART VALVE" UMIT O¨ ZYURDAA, A. RUCHAN AKARA,*, OZGE UYMAZA, MEHMET OGUZB, MEHMET OZKANB, CELIL YILDIRIMB, ALP ASLANB, REFIK TASOZA. THIS PUBLICATION REPORTS ON 400 PATIENTS AGED 19¿85 YEARS (MEAN: 55.6 ± 16), 290 MALES AND 210 FEMALES IMPLANTED BETWEEN DECEMBER 2000 AND JANUARY 2003. THERE WERE 120 CASES OF AORTIC VALVE REPLACEMENT (AVR), 258 MITRAL VALVE REPLACEMENT (MVR) AND 22 COMBINED AORTIC AND MITRAL VALVE REPLACEMENT (DVR). ADDITIONAL PROCEDURES WERE PERFORMED IN 144 PATIENTS. PATIENTS WERE FOLLOWED UP PROSPECTIVELY AT 3- TO 6-MONTH INTERVALS. MEAN FOLLOW-UP WAS 38.4 ± 11.8 MONTHS (MAXIMUM 55.6 MONTHS). OVERALL HOSPITAL MORTALITY WAS 3.5%. FREEDOM FROM ADVERSE EVENTS AT 4 YEARS IN THE STUDY WERE AS FOLLOWS: THROMBOEMBOLISM, 99.1% FOR AVR, 98.3% FOR MVR AND 94.7% FOR DVR PATIENTS; THROMBOSIS, 100% FOR AVR, 99.2% FOR MVR AND 94.7% FOR DVR; BLEEDING EVENTS, 99.1% FOR AVR, 99.2% FOR MVR AND 88.8% FOR DVR; PROSTHETIC ENDOCARDITIS, 98.2% FOR AVR, 99.2% FOR MVR AND 94.7% FOR DVR. OVERALL SURVIVAL AT 4 YEARS WAS 92 ± 1%. AT ECHOCARDIOGRAPHICAL EXAMINATION WITHIN 1 YEAR OF THE AVR, THE MEAN AORTIC VALVE GRADIENT WAS 12.8±6, 10.3±3, 9.0±4, 8.3±3, AND 6.2±3 MMHG FOR 19, 21, 23, 25, 27Y29 MM VALVE SIZES, RESPECTIVELY. MVR MEAN GRADIENT WAS 4.9±2, 4.5±1.2 AND 4.0±0.8 MMHG FOR 25, 27Y29, 31Y33 MM VALVE SIZES. CONCLUSION: THIS STUDY DEMONSTRATED THE EARLY CLINICAL AND HEMODYNAMIC PERFORMANCE OF THE ON-X MECHANICAL BILEAFLET PROSTHESIS IN THE AORTIC AND MITRAL POSITIONS TO BE SATISFACTORY WITH AN ACCEPTABLE EARLY MORTALITY AND MORBIDITY. THIS INVESTIGATION IS RELEGATED TO ONX OF UNKNOWN CONFIGURATION FOR THROMBOEMBOLISM, THROMBOSIS, PROSTHETIC VALVE ENDOCARDITIS, NON-STRUCTURAL VALVE DETERIORATION (PARAVALVULAR LEAKS) AND RE-OPERATION, CARDIAC FAILURE, ISCHEMIA, HEMORRHAGE, AND MORTALITY. NO SERIAL NUMBERS (SN) ARE KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1885835 | 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 | Life Threatening| H| R| D |