MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL

Model Number ONXA UNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Congenital Defect/Deformity (1782); Connective Tissue Disease (1786); Endocarditis (1834); Ventricle, Abnormality Of (2078)

Event Type  Death  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

Per the publication by myers et al titled "outcomes after mechanical aortic valve replacement in children and young adults with congenital heart disease," the outcomes were ¿7 early deaths (valve not defined), 10 unplanned re-operations (valve not defined), 10 late deaths (valve not defined), 4 early thromboembolic events (including 3 strokes) (valve not defined), 5 early bleeding events (valve not defined), 1 prosthetic valve endocarditis (valve not defined)." the publication results were "median age at avr [aortic valve replacement] was 16 years (interquartile range, 12-22.8 years).The valves implanted were the st.Jude valve (st.Jude medical inc., st.Paul minnesota) in 79 patients (62%), the on-x valve (on-x life technologies inc., austin, texas) in 45 patients (35%), and carbomedics (sarin spa, milan, italy) in 3 patients {2.4%).Median valve size was 23 mm (range 21-25 mm).There were 5 early deaths (3.9%).Median follow-up was 5 years (range, 1.6-9.2 years; 600 patient-years).There were 14 deaths during follow-up.Survival was 90.6+/- 2.8% at 1 year, 85.4% +/- 3.7% at 5 years, and 81.5% +/- 4.5% at 10 years.Freedom from aortic valve re-operation was 98% +/- 1.4% at 1 and 5 years, 91.5% +/- 3.9% at 7 years, 78.4% +/- 6.9% at 10 years and at latest follow-up.Uni-variable analysis identified younger age, lower weight, and use of 16 mm carbomedics valve as predictors for re-operation.Valve sizes of 16 or 17 mm have a significantly higher risk of re-operation compared with larger valves (log-rank test, p<.001).At multivariate analysis, only younger age was a significant independent predictor of re-operation (hazard ration, 0.84; 95% confidence interval, 0.71-0.99; p=.038).All patients were treated with warfarin to a goal international normalized ration of 2.0 to 3.0.Four patients (3.1%; 0.66% per patient-year) had thromboembolic complications, and 5 patients (3.9%; 0.83% per patient-year) had bleeding events during follow-up".

Manufacturer Narrative

According to the initial report, the publication by myers et al.2018 titled ¿outcomes after mechanical aortic valve replacement in children and young adults with congenital heart disease,¿ which evaluated the outcomes of mechanical aortic valve replacement (avr) in children and young adults with congenital aortic valve disease by analyzing survival and associated thromboembolic (te) and bleeding complications, states the outcomes: ¿7 early deaths (valve not defined), 10 unplanned re-operations (valve not defined), 10 late deaths (valve not defined), 4 early thromboembolic events (including 3 strokes) (valve not defined), 5 early bleeding events (valve not defined), and 1 prosthetic valve endocarditis (valve not defined)." the results listed in the abstract of the publication stated: "median age at avr [aortic valve replacement] was 16 years (interquartile range, 12-22.8 years).The valves implanted were the st.Jude valve (st.Jude medical inc., st.Paul minnesota) in 79 patients (62%), the on-x valve (on-x life technologies inc., austin, texas) in 45 patients (35%), and carbomedics (sarin spa, milan, italy) in 3 patients {2.4%).Median valve size was 23 mm (range 21-25 mm).There were 5 early deaths (3.9%).Median follow-up was 5 years (range, 1.6-9.2 years; 600 patient-years).There were 14 deaths during follow-up.Survival was 90.6+/- 2.8% at 1 year, 85.4% +/- 3.7% at 5 years, and 81.5% +/- 4.5% at 10 years.Freedom from aortic valve re-operation was 98% +/- 1.4% at 1 and 5 years, 91.5% +/- 3.9% at 7 years, 78.4% +/- 6.9% at 10 years and at latest follow-up.Univariable analysis identified younger age, lower weight, and use of 16 mm carbomedics valve as predictors for re-operation.Valve sizes of 16 or 17 mm have a significantly higher risk of re-operation compared with larger valves (log-rank test, p<.001).At multivariate analysis, only younger age was a significant independent predictor of re-operation (hazard ration, 0.84; 95% confidence interval, 0.71-0.99; p=.038).All patients were treated with warfarin to a goal international normalized ration of 2.0 to 3.0.Four patients (3.1%; 0.66% per patient-year) had thromboembolic complications and 5 patients (3.9%; 0.83% per patient-year) had bleeding events during follow-up." a review of the available information was performed.It was noted that the values and number of events reported in the abstract do not align with those reported in the body of the publication.It is impossible based on the available information to determine the correct value and permit accurate comparison to previously published rates.Additionally, the corresponding valve manufacturer was not reported along with event values, so it is impossible to determine what subset of events occurred with the on-x valve and what occurred with the other valves.However, it was noted that no on-x patients required re-operation.Definitive root causes for the reported events cannot be determined based on the available information.Though it was noted that age was an independent predictor of re-operation (hr 0.84%, 5% confidence interval 0.71-0.99, p=0.038).Objective performance criteria for late events for rigid valves [iso 5840:2005 (opc)] report the following rates: thromboembolism 3.0%/pt-yr, all hemorrhage 1.5%/pt-yr, and thrombosis 0.8%/pt-yr.Despite the lack of congruency between reported values, the body of the publication reported te complications at 0.66%/pt-yr and bleeding events at 0.83%/pt-yr, which are both less than the opc.The on-x heart valve risk management file thoroughly identifies the process and product hazards for approved indication.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and instructions for use (ifu) and all adverse events reported are recognized risk factors for mechanical valve replacement and are indicated in the ifu.No further action is warranted at this time.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 cryolife is accurate or has been confirmed by cryolife.

Event Description

Per the publication by myers et al titled "outcomes after mechanical aortic valve replacement in children and young adults with congenital heart disease," the outcomes were ¿7 early deaths (valve not defined), 10 unplanned re-operations (valve not defined), 10 late deaths (valve not defined), 4 early thromboembolic events (including 3 strokes) (valve not defined), 5 early bleeding events (valve not defined), 1 prosthetic valve endocarditis (valve not defined)." the publication results were "median age at avr [aortic valve replacement] was 16 years (interquartile range, 12-22.8 years).The valves implanted were the st.Jude valve (st.Jude medical inc., st.Paul minnesota) in 79 patients (62%), the on-x valve (on-x life technologies inc., austin, texas) in 45 patients (35%), and carbomedics (sarin spa, milan, italy) in 3 patients {2.4%).Median valve size was 23 mm (range 21-25 mm).There were 5 early deaths (3.9%).Median follow-up was 5 years (range, 1.6-9.2 years; 600 patient-years).There were 14 deaths during follow-up.Survival was 90.6+/- 2.8% at 1 year, 85.4% +/- 3.7% at 5 years, and 81.5% +/- 4.5% at 10 years.Freedom from aortic valve re-operation was 98% +/- 1.4% at 1 and 5 years, 91.5% +/- 3.9% at 7 years, 78.4% +/- 6.9% at 10 years and at latest follow-up.Uni-variable analysis identified younger age, lower weight, and use of 16 mm carbomedics valve as predictors for re-operation.Valve sizes of 16 or 17 mm have a significantly higher risk of re-operation compared with larger valves (log-rank test, p<.001).At multivariate analysis, only younger age was a significant independent predictor of re-operation (hazard ration, 0.84; 95% confidence interval, 0.71-0.99; p=.038).All patients were treated with warfarin to a goal international normalized ration of 2.0 to 3.0.Four patients (3.1%; 0.66% per patient-year) had thromboembolic complications, and 5 patients (3.9%; 0.83% per patient-year) had bleeding events during follow-up.".

• Brand Name: ON-X PROSTHETIC AORTIC VALVE UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8701521
• MDR Text Key: 148141559
• Report Number: 1649833-2019-00038
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXA UNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other; Required Intervention