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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Embolism (1829); Hemorrhage/Bleeding (1888); Thrombus (2101); Sudden Cardiac Death (2510)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to publication, "outcomes of valve replacement with mechanical prosthesis versus bioprosthesis in dialysis patients: a 16-year multicenter experience" by ikeno, md et al.Objective: to evaluate the long-term outcomes of heart valve replacement with mechanical prosthesis (mp) versus bioprosthesis (bp) in patients on dialysis.Methods: a retrospective review was performed at 7 hospitals.Patients on dialysis who underwent valve replacement were included.Survival, reoperation, bleeding, and embolic events were compared across the mp and bp groups.Results: between april 2000 and april 2016, 312 patients on dialysis were enrolled in our study (mp: 94 patients [30.1%], bp: 218 patients [69.9%]).Mean follow-up was 3.43.6 years.Five-year and 10-year survival rates were similar in both groups (mp: 57.45.5% at 5 years and 46.36.4% at 10 years, bp: 50.24.1% at 5 years and 38.84.5% at 10 years,p=.305).Multivariate cox hazard analysis demonstrated that diabetic nephropathy (hazard ratio [hr],1.90; 95%confidence interval [ci], 1.31-2.73,p<.001), new york heart association functional classification iii (hr, 2.16; 95%ci, 1.37-3.35,p<.001), and mitral valve replacement (hr, 2.36; 95%ci, 1.58-3.49,p<.001) were significant risk factors for late death.Valve selection was not a significant risk factor.Freedom from valve-related embolic event at 5 years was significantly lower in the mp group (mp: 88.34.3% at 5 years, bp: 97.21.6% at 5 years,p<.007).Freedom from valve-related reoperation or hemorrhagic events was similar across both groups.Conclusions: valve selection was not associated with late survival outcomes inpatients on dialysis.However, bp may have an advantage in preventing embolic events without increasing the incidence of valve-related reoperation when compared with mp.No event is correlated with a specific manufacturer.There were 30 total on-x valves implanted.Early outcomes- hospital mortality: mp 14.9% (14/94).Late outcomes- late death: mp 28.Pannus: mp 2.Thrombus: mp 1.Bleeding: mp 6.Embolic events: mp 10.

Manufacturer Narrative

A review of the available information was.According to publication, "outcomes of valve replacement with mechanical prosthesis versus bioprosthesis in dialysis patients: a 16-yearmulticenter experience by lkeno, md et al objective: to evaluate the long-term outcomes of heart valve replacement with mechanical prosthesis (mp) versus bioprosthesis (bp)in patients on dialysis.Methods: a retrospective review was performed at 7 hospitals.Patients on dialysis who underwent valve replacement were included.Survival, reoperation, bleeding, and embolic events were compared across the mp and bp groups.Results: between (b)(6) 2000 and (b)(6) 2016, 312 patients on dialysis were enrolled in our study (mp:94 patients [30.1%), bp:218 patients (69.9%)).Mean follow-up was 3.43.6 years.Five-year and 10-year survival rates were similar in both groups (mp: 57.45.5% at 5 years and 46.36.4% at 10 years.Bp:50.24.1% at 5 years and 38.84.5% at 10 years.P=.305).Multivariate cox hazard analysis demonstrated that diabetic nephropathy (hazard ratio (hr).1.90:95% confidence interval (cl).1.31-2.73, p<.001).New york heart association functional classification iii (hr.2.16: 95%ci.1.37-3.35.P<.001), and mitral valve replacement (hr.2.36; 95%ci.1.58-3.49, p<.001) were significant risk factors for late death.Valve selection was not a significant risk factor.Freedom from valve-related embolic event alt 5 years was significantly lower in the mp group (mp:88.34.3% at 5 years.Bp: 97.21.6% at 5 years, p<.007).Freedom from valve-related reoperation or hemorrhagic events was similar across both groups.Conclusions: valve selection was not associated with late survival outcomes in patients on dialysis.However, bp may have an advantage in preventing embolic events without increasing the incidence of valve-related reoperation when compared with mp.Early outcomes hospital mortality: mp 14.Bp 38; late outcomes; late death: mp 28.Bp 57; pannus: mp 2; thrombus: mp 1; bleeding: mp 6; embolic events: mp 10.Note: the corresponding valve manufacturer was not reported along with event values so itis impossible to determine what subset of events occurred with the on-x valve and what occurred with the other valves.There were 30 total on-x valves implanted.The study concluded the following: five-year and 10-year survival rates were similar in both groups.Multivariate cox hazard analysis demonstrated that diabetic nephropathy, new york heart association functional classification 111, and mitral valve replacement were significant risk factors for late death.Valve selection was not a significant risk factor.Freedom from valve-related embolic event al 5 years was significantly lower in the mp group.Freedom from valve-related reoperation or hemorrhagic events was similar across both groups.Despite these results (freedom from reoperation and hemorrhagic events similar between groups), reports have generally concluded that bp are associated with a greater risk of reoperation and a decreased probability of bleeding and embolic events compared to mp.As such, definitive root causes for the reported events cannot be determined based on the available information.Specific features of patients on dialysis, various platelet and coagulation abnormalities, routine use of heparin, and accelerated vascular calcification, may explain the greater incidence of thromboembolic events in patients on dialysis with mp than in the general population.Subtherapeutic inr values due to anticoagulation noncompliance may have also contributed to the higher incidence of thromboembolic events.However, this cannot be confirmed.Regardless, all adverse events reported are recognized risk factors for mechanical valve replacement and are indicated in the ifu.Definitive root causes for the reported events cannot be determined.Specific features of patients on dialysis, various platelet and coagulation abnormalities, routine use of heparin, and accelerated vascular calcification, may explain the greater incidence of thromboembolic events in patients on dialysis with mp than in the general population.Subtherapeutic inr values due to anticoagulation noncompliance may have also contributed to the higher incidence of thromboembolic events.However, this cannot be confirmed.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.No further action required.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.

• Brand Name: ON-X PROSTHETIC 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: 8760952
• MDR Text Key: 150029540
• Report Number: 1649833-2019-00045
• 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: foreign,study
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/25/2019
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 09/12/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other