ON-X VALVE UNKNOWN CONFIGURATION
Report
- Report Number
- 1649833-2024-00056
- Event Type
- Death
- Date Received
- October 31, 2024
- Report Date
- December 18, 2024
- Manufacturer
- ARTIVION, INC.
- Product Code
- LWQ
- PMA / PMN Number
- P000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ACCORDING TO PUBLICATION, "THE ON-X PROSTHETIC HEART VALVE AT FIVE YEARS", REINHARD MOIDL, MD, PAUL SIMON, MD, ERNST WOLNER, MD, AND MEMBERS OF THE ON-X PROSTHESIS HEART VALVE TRIAL¿, THIS PUBLICATION REPORTS ON 532 PATIENTS THAT UNDERWENT IMPLANTATION, 303 FOR AORTIC VALVE REPLACEMENT (AVR) AND 229 FOR MITRAL VALVE REPLACEMENT (MVR), AT 20 CENTERS FROM SEPTEMBER 1996 TO JULY 2001. THE STUDY FOLLOWED THE GUIDELINES OF THE AATS/STS. MEAN FOLLOW-UP WAS 23 MONTHS (TOTAL 1024 PATIENT-YEARS; MAXIMUM 5 YEARS). POOLABILITY ANALYSIS WAS PERFORMED TO SHOW THE EQUIVALENCE OF THE POPULATIONS. RESULTS. PATIENTS AND RESULTS WERE FOUND TO BE SIMILAR AND POOLABLE. FREEDOM FROM ADVERSE EVENTS AT 2 YEARS IN THE STUDY WERE AS FOLLOWS: THROMBOEMBOLISM, 96.0% FOR AVR PATIENTS AND 96.3% FOR MVR; THROMBOSIS, 100% FOR AVR AND 100% FOR MVR; BLEEDING EVENTS, 96.6% FOR AVR AND 95.7% FOR MVR; AND OVERALL MORTALITY, 95.2% FOR AVR AND 92.4% FOR MVR. MEDIAN LACTATE DEHYDROGENATE LEVELS WERE IN THE NORMAL RANGE FOR AVR AND MVR PATIENTS AT ALL INTERVALS. AT 1 YEAR, AVR ECHOCARDIOGRAPHIC RESULTS FOR THE 19 TO 25 VALVES, RESPECTIVELY, RANGED FROM 1.5 TO 2.8 CM2 FOR EFFECTIVE ORIFICE AREA AND 9.2 TO 4.7 MM HG FOR MEAN GRADIENT, AND MVR EFFECTIVE ORIFICE AREA BY PRESSURE HALF-TIME WAS 2.8 CM2 AND MEAN GRADIENT WAS 4.2 MM HG. CONCLUSIONS. THE TWO TRIALS HAVE GIVEN SIMILARLY EXCELLENT RESULTS FOR THE ON-X VALVE. THIS INVESTIGATION IS RELEGATED TO ONX OF UNKNOWN CONFIGURATION FOR A TOTAL OF 76 EVENTS: THROMBOEMBOLISM ¿ 21, ENDOCARDITIS ¿ 5, PARAVALVULAR LEAK ¿ 13, BLEEDING ¿ 32, MORTALITY - 5 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 LOT/SERIAL NUMBER AND DATE OF SURGERY WERE NOT PROVIDED BY THE COMPLAINANT. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE PUBLICATION ¿THE ON-X PROSTHETIC HEART VALVE AT FIVE YEARS¿ BY MOIDL ET ALL PUBLISHED IN 2002 IS REVIEWED HERE. DATA CONSISTS OF 532 PATIENTS FROM A MULTICENTER CLINICAL TRIAL IN EUROPE AND NORTH AMERICA FROM 20 CENTERS WAS REVIEWED. IMPLANTS OCCURRED BETWEEN SEPTEMBER 1996 TO JULY 2001 USING THE ON-X VALVE IN THE AORTIC AND/OR MITRAL POSITION (AORTIC=303, MITRAL=229). PATIENTS WERE INCLUDED IF THEY WERE ADULTS WHO UNDERWENT ISOLATED PROSTHETIC VALVE REPLACEMENT USING THE ON-X VALVE IN THE AORTIC AND/OR MITRAL POSITION AND DID NOT MEET AN EXCLUSION CRITERION. CLINICAL OUTCOMES OF ISOLATED AORTIC AND MITRAL VALVE REPLACEMENT WITH THE ON-X VALVE WERE EVALUATED IN TERMS OF MORTALITY, VALVE-RELATED ADVERSE EVENTS, ECHOCARDIOGRAPHIC HEMODYNAMICS, BLOOD DAMAGE, QUALITY OF LIFE, AND NEW YORK HEART ASSOCIATION (NYHA) CLASSIFICATION. IN THE AVR GROUP, 68.6% OF PATIENTS WERE MALE, WHEREAS IN THE MVR GROUP, 38% WERE MALE. THE MEAN AGE AT IMPLANT WAS 59.6 ± 9.1 YEARS IN AVR PATIENTS (RANGE 20 TO 85 YEARS) AND 59.2 ± 10.6 YEARS IN MVR (RANGE 21 TO 78 YEARS). PREOPERATIVELY THE MAJORITY OF PATIENTS WERE IN NYHA CLASSES II OR III AND AVR PATIENTS WERE IN SINUS RHYTHM 89.4% AND MVR PATIENTS 56.3% OF THE TIME. THE PREDOMINANT VALVE PATHOLOGY IN AVR PATIENTS WAS CALCIFIC (56.3%), CONGENITAL BICUSPID (35.2%) OR DEGENERATIVE (15.5%), WHILST AMONG MVR PATIENTS IT WAS RHEUMATIC (36.6%), DEGENERATIVE (33.1%) OR CALCIFIC (12.7%). THE AORTIC VALVE LESION WAS STENOTIC (45.1%), MIXED (41.5%) AND REGURGITANT (13.4%), WHILE THE MITRAL LESION WAS REGURGITANT (48.6%), MIXED (43.0%) OR STENOTIC (5.6%). SCHEDULED FOLLOW-UP OCCURRED AT 3 TO 6 MONTHS POSTOPERATIVELY AND AT ANNUAL POSTOPERATIVE INTERVALS TO AT LEAST 5 YEARS. TOTAL FOLLOW-UP IN THE STUDY WAS 606.0 PATIENT-YEARS FOR AVR PATIENTS AND 417.9 PATIENT-YEARS FOR MVR. ECHOCARDIOGRAPHIC DATA WERE GATHERED AT DISCHARGE AND AT 1-YEAR, POSTOPERATIVE BLOOD SAMPLES FOR HEMOLYSIS WERE TAKEN AT 3 TO 6 MONTHS AND ANNUALLY, AND THE NYHA FUNCTIONAL CLASSIFICATION WAS EVALUATED AT EACH FOLLOW-UP IN ACCORDANCE WITH THE DEFINITIONS OF THAT SOCIETY. HOSPITAL MORTALITY IN THE STUDY WAS 2.44% (13/532) FOR THE WHOLE STUDY, AT 1.32% FOR AVR PATIENTS AND 3.93% FOR MVR. ONE AVR PATIENT DIED OF MULTIPLE ORGAN FAILURE, 3 MVR PATIENTS FROM SEPSIS, 5 PATIENTS (2 AVR AND 3 MVR) FROM ARRHYTHMIAS DETERMINED BY AUTOPSY TO BE NOT RELATED TO THE VALVE, 1 AVR PATIENT FROM THROMBOEMBOLISM 10 DAYS POSTOPERATIVELY, 1 MVR PATIENT FROM VENTRICULAR RUPTURE, 1 MVR PATIENT FROM A PERIOPERATIVE BLEED, AND 1 MVR PATIENT FROM CANCER. THERE WERE 17 LATE DEATHS IN THE STUDY (8 AVR PATIENTS, 1.32%/PATIENT-YEARS; AND 9 MVR PATIENTS, 2.15%/PATIENT-YEARS). THE ACTUARIAL FREEDOM FROM DEATH AT 2 YEARS (FIG 2) IN THE STUDY WAS 95.2% ± 1.4% IN AVR PATIENTS AND 92.4% ± 2.0% IN MVR, AND THE FREEDOM FROM VALVE-RELATED OR SUDDEN DEATH WAS 97.4% ± 1.4% IN AVR PATIENTS AND 99.5% ± 0.5% IN MVR. EARLY THROMBOEMBOLIC EVENTS OCCURRED IN 4 AVR PATIENTS (1.32%) AND 2 MVR PATIENTS (0.87%). LATE THROMBOEMBOLIC EVENTS OCCURRED 15 TIMES, IN 8 AVR PATIENTS (1.32%/ PATIENT-YEARS) AND IN 7 MVR (1.68%/PATIENT-YEARS). OVERALL FREEDOM FROM THROMBOEMBOLISM AT 2 YEARS (FIG 3) WAS 96.0% 1.3% AVR AND 96.3% ± 1.4% MVR. THERE WERE NO THROMBOSED VALVES REPORTED IN THESE PATIENTS. EARLY BLEEDING EVENTS OCCURRED THREE TIMES (0.99%) IN AVR PATIENTS AND 4 TIMES (1.75%) IN MVR. LATE BLEEDING EVENTS OCCURRED 10 TIMES (1.65%/ PATIENT-YEARS) IN AVR PATIENTS AND SIX TIMES (1.44%/ PATIENT-YEARS) IN MVR. LATE MAJOR BLEEDING EVENTS OCCURRED SEVEN TIMES (1.16%/PATIENT-YEARS) IN AVR AND TWO TIMES (0.48%/PATIENT-YEARS) IN MVR. AT 2 YEARS, THE ACTUARIAL FREEDOM FROM BLEEDING WAS 96.6% ± 1.2% IN AVR PATIENTS AND 95.7% ± 1.5% IN MVR (FIG 4). PROSTHETIC ENDOCARDITIS OCCURRED IN 5 PATIENTS, ALL LATE BUT WITHIN THE FIRST YEAR POSTOPERATIVELY: 2 AVR PATIENTS (0.33%/PATIENT-YEARS) AND 3 MVR (0.72%/PATIENT-YEARS). THE ACTUARIAL FREEDOM FROM ENDOCARDITIS AT 2 YEARS WAS 99.2% ± 0.6% AVR AND 99.0% ± 0.7% MVR. THERE WERE NO CASES OF STRUCTURAL VALVE FAILURE. NONSTRUCTURAL VALVE FAILURE IN THE FORM OF PARAVALVULAR LEAKS OCCURRED IN 13 PATIENTS (7 EARLY AND 6 LATE). TWO EARLY EVENTS WERE TISSUE TEARS IN 1 AVR PATIENT (0.33%) AND 1 MVR (0.44%), AND THE REMAINING EARLY EVENTS WERE MINOR LEAKS FOUND ON ECHOCARDIOGRAPHIC EXAMINATION AND NOT TREATED (4 AVR AND 1 MVR). THREE AVR PATIENTS (0.50%/PATIENT-YEARS) AND 3 MVR PATIENTS (0.72%/ PATIENT-YEARS) HAD PARAVALVULAR LEAKS LATE POSTOPERATIVELY. THE ACTUARIAL FREEDOM FROM PARAVALVULAR LEAK AT 2 YEARS WAS 97.8 ± 0.9 FOR AVR AND 97.2 ± 1.2 FOR MVR. TOTAL ACTUARIAL FREEDOM FROM VALVE-RELATED MORBIDITY AND MORTALITY AT 2 YEARS WAS 88.4% ± 2.1% FOR AVR AND 88.0% ± 2.5% FOR MVR. AT 1 YEAR POSTOPERATIVELY, 90.7% OF AVR PATIENTS AND 95.8% OF MVR PATIENTS WERE IN NYHA CLASS I OR II. NO EVIDENCE OF HEMOLYTIC ANEMIA WAS FOUND. RESULTS WERE CONSISTENT ACROSS ALL POSTOPERATIVE EXAMINATIONS TO 2 YEARS. IMPORTANTLY, THE MEDIAN SERUM LACTATE DEHYDROGENASE LEVEL , ALTHOUGH INCREASED FROM PREOPERATIVE VALUES, WAS WITHIN THE NORMAL RANGE FOR ALL VALVE TYPES AT EACH INTERVAL, WHICH IS ATYPICAL FOR MECHANICAL VALVES. COMPARING DIRECTLY TO THE HISTORICAL RECORD OBJECTIVE PERFORMANCE CRITERIA (OPC) [ISO 5840-2:2021(E)], AORTIC THROMBOEMBOLISM (TE) OCCURRED AT A RATE OF 1.32%/PATIENT-YEAR (PT-YR) COMPARED TO THE OPC OF 1.6%/PT-YR. FOR THE MITRAL POSITION, TE RATES WERE 1.68%/PT-YR COMPARED TO 2.2 %/PT-YR. AORTIC PARAVALVULAR LEAK OCCURRED AT A RATE OF 0.5%/PATIENT-YEAR (PT-YR) COMPARED TO THE OPC OF 0.3%/PT-YR. MITRAL PARAVALVULAR LEAK OCCURRED AT A RATE OF 0.72%/PATIENT-YEAR (PT-YR) COMPARED TO THE OPC OF 0.5%/PT-YR. OF NOTE, THE OPC RATE IS FOR MAJOR PVL AND THE PUBLICATION DID NOT DIFFERENTIATE BETWEEN MINOR AND MAJOR PVL. AORTIC ENDOCARDITIS OCCURRED AT A RATE OF 0.33 %/PATIENT-YEAR (PT-YR) COMPARED TO THE OPC OF 0.3%/PT-YR. MITRAL ENDOCARDITIS OCCURRED AT A RATE OF 0.72%/PATIENT-YEAR (PT-YR) COMPARED TO THE OPC OF 0.3%/PT-YR. HOWEVER, HISTORICAL OPC¿S FROM THE TIME OF PUBLICATION (2005) SHOW THE ENDOCARDITIS RATE FOR RIGID HEART VALVE SUBSTITUTES IS 1.2%/PATIENT-YEAR (PT-YR). LATE MAJOR BLEEDING EVENTS OCCURRED AT A RAT3E 1.16%/PATIENT-YEARS FOR AORTIC AND AT A RATE OF 0.48%/PATIENT-YEARS FOR MITRAL, COMPARED TO THE OPC FOR AORTIC 1.6 %/PT-YR AND MITRAL 1.4%/PT-YR. MORTALITY AND ALL INDICATED COMPLICATIONS ARE RECOGNIZED IN THE VALVE¿S INSTRUCTIONS FOR USE [IFU]. THE AUTHORS CONCLUDE THAT THE ON-X VALVE PERFORMS SATISFACTORILY IN THE FIRST 5-YEAR PERIOD IN ISOLATED VALVE REPLACEMENT. CLINICAL OUTCOMES ANALYSIS FOR A MULTI-CENTER EXPERIENCE WITH 5 YEARS FOLLOW-UP OF ON-X PROSTHETIC HEART VALVES IN THE AORTIC AND/OR MITRAL POSITION OF 532 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. 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 TO PUBLICATION, "THE ON-X PROSTHETIC HEART VALVE AT FIVE YEARS", REINHARD MOIDL, MD, PAUL SIMON, MD, ERNST WOLNER, MD, ET AL. THIS PUBLICATION REPORTS ON 532 PATIENTS THAT UNDERWENT IMPLANTATION, 303 FOR AORTIC VALVE REPLACEMENT (AVR) AND 229 FOR MITRAL VALVE REPLACEMENT (MVR), AT 20 CENTERS FROM SEPTEMBER 1996 TO JULY 2001. THE STUDY FOLLOWED THE GUIDELINES OF THE AATS/STS. MEAN FOLLOW-UP WAS 23 MONTHS (TOTAL 1024 PATIENT-YEARS; MAXIMUM 5 YEARS). POOLABILITY ANALYSIS WAS PERFORMED TO SHOW THE EQUIVALENCE OF THE POPULATIONS. RESULTS. PATIENTS AND RESULTS WERE FOUND TO BE SIMILAR AND POOLABLE. FREEDOM FROM ADVERSE EVENTS AT 2 YEARS IN THE STUDY WERE AS FOLLOWS: THROMBOEMBOLISM, 96.0% FOR AVR PATIENTS AND 96.3% FOR MVR; THROMBOSIS, 100% FOR AVR AND 100% FOR MVR; BLEEDING EVENTS, 96.6% FOR AVR AND 95.7% FOR MVR; AND OVERALL MORTALITY, 95.2% FOR AVR AND 92.4% FOR MVR. MEDIAN LACTATE DEHYDROGENATE LEVELS WERE IN THE NORMAL RANGE FOR AVR AND MVR PATIENTS AT ALL INTERVALS. AT 1 YEAR, AVR ECHOCARDIOGRAPHIC RESULTS FOR THE 19 TO 25 VALVES, RESPECTIVELY, RANGED FROM 1.5 TO 2.8 CM2 FOR EFFECTIVE ORIFICE AREA AND 9.2 TO 4.7 MM HG FOR MEAN GRADIENT, AND MVR EFFECTIVE ORIFICE AREA BY PRESSURE HALF-TIME WAS 2.8 CM2 AND MEAN GRADIENT WAS 4.2 MM HG. CONCLUSIONS. THE TWO TRIALS HAVE GIVEN SIMILARLY EXCELLENT RESULTS FOR THE ON-X VALVE. THIS INVESTIGATION IS RELEGATED TO ONX OF UNKNOWN CONFIGURATION FOR THROMBOEMBOLISM, THROMBOSIS, PARAVALVULAR LEAK, BLEEDING AND MORTALITY. NO SERIAL NUMBERS (SN) ARE KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1982430 | ON-X VALVE UNKNOWN CONFIGURATION | HEART-VALVE, MECHANICAL | LWQ | ARTIVION, INC. | ONX UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H| D| L |