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

Model Number ONXM UNK

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

Patient Problems Death (1802); Endocarditis (1834); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Blood Loss (2597)

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the publication "on-x versus st jude medical mechanical prosthesis, in mitral position: are we moving forward in design technology?" by mostafa, et.Al.(midany), a comparative study was conducted from june 2009 to december 2015 on 360 patients who underwent mitral valve replacement using sjm or on-x mechanical valves.On-x valves(n=180) and st jude valves(n=180).Summary of the outcomes from the publication include: 1.Early mortality (6.4%) 2.Thrombosis lor= 1.9%/patient-year for onx and 2.1%/patient-year for sjm, mean inr was 1.7 in patients presenting with thrombosis 3.No embolic events in either group 4.Postop bleeding= 2.7% for onx and 3.8% for sjm 5.Neurologic insults occurred in 1.6% of onx and 1.1% of sjm group 6.2 onx patients had endocarditis 7.Hemodynamics appeared similar but numerically better for onx valves.8.Eoai was higher in onx group (1.1 cm2/m2) thn sjm (1.0 cm2/m2) with p = 0.034 a.This was most significant in small sized valves 25mm- 1.09 cm2/m2 for onx compared to 0.93 cm2/m2 for sjm, p=0.02.9.Incidence of patient prosthesis mismatch was less in onx, but not statistically significant.A.No ppm: 43% onx and 35% sjm b.Moderate ppm: 55% onx and 64% sjm c.Severe ppm: 2% onx and 1% sjm.Additionally, the publication states, "though we noted valvular thrombotic events due to subtherapeutic inr, there wereno embolic events in both groups" and "all hospital mortalities were not valve related.".

Manufacturer Narrative

Multiple requests to the contact author for additional clarifying information were made without success to acquire the following information: dates of the on-x implants, serial numbers of the on-x valves, any adverse events that occurred for on-x valve patients, and the current patient status of the on-x valve recipients.No response was received.The manufacturing records for the on-x valves used in the study were not reviewed as the serial numbers were not provided.The system could not be queried for the on-x valves as dates of implant were not provided.A review of the available information was performed.Pre-publication journal article accepted but not yet finalized reprising a single center's prospective, randomized, comparison clinical outcome study between 180 on-x and 180 st.Jude medical mechanical mitral valve cases.By most measures, the clinical outcomes between the two valves were very similar, with, perhaps, a slight edge in favor of the on-x valve.A summary of findings follows: mean follow-up was 3.11 ± 2.44 years.Similarities ¿ all hospital mortalities were not valve-related.No thromboembolic events in either group.No early thrombosis for either valve.Late thrombosis = 1.9%/patient-year for on-x and 2.1%/patient-year for sjm, not statistically significant: mean inr (international normalized ratio) was 1.7 for all patients presenting with thrombosis (i.E.Sub-therapeutic inr: typical recommended inr range for mitral mechanical valves is 2.5 - 3.5).All bleeding episodes reported were immediately postoperative due to medical coagulation disorders.There were 2.7% on-x cases and 3.8% sjm, but not statistically different.There were no late bleeding episodes reported over the time of postoperative follow-up.Neurologic insults occurred in 1.6% of on-x (3 cases) and 1.1% of sjm (2 cases).No structural or non-structural valvular dysfunction for either valve.Patient prosthesis mismatch was less in on-x, but not statistically significant between the two.Peak gradient, mean gradient, and effective orifice area (eoa) all favored the on-x valve, but not of statistical significance.Difference - mean effective orifice area index (eoai) was larger in on-x group (1.1 cm2/m2) than sjm (1.0 cm2/m2) with p = 0.034.This was most significant in small sized valves: 25mm- 1.09 cm2/m2 for onx compared to 0.93 cm2/m2 for sjm,p=0.02.There were two cases of paravalvular leak (pvl) secondary to endocarditis for the on-x valve group.All adverse events reported are recognized risk factors for mechanical mitral valve replacement.(instructions for use (ifu)).Compared to objective performance criteria (opc) for late events for rigid valves (iso (b)(4)): thromboembolism 3.0 %/patient-year and all hemorrhage 1.5 %/patient-year were better, but thrombosis 0.8 %/patient-year a little worse.All pvl 1.2 %/patient-year and endocarditis 1.2 %/patient-year were comparable or better.All reported events are recognized by the ifu and comparable to objective performance criteria.Post production residual risk is communicated in the product's labeling and ifu.Adverse events potentially associated with the use of prosthetic heart valves include angina, prosthesis structural dysfunction, cardiac arrhythmia, prosthesis thrombosis, endocarditis, stroke, heart failure, thromboembolism, hemolysis, hemolytic anemia, hemorrhage, myocardial infarction, prosthesis leaflet entrapment (impingement), and prosthesis nonstructural dysfunction.It is possible that these complications could lead to reoperation, explantation, permanent disability, and death.

Event Description

According to the publication "on-x versus st jude medical mechanical prosthesis, in mitral position: are we moving forward in design technology?" by mostafa, et.Al.(midany), a comparative study was conducted from june 2009 to december 2015 on 360 patients who underwent mitral valve replacement using sjm or on-x mechanical valves.On-x valves(n=180) and st jude valves(n=180).Summary of the outcomes from the publication include: 1.Early mortality (6.4%) 2.Thrombosis lor= 1.9%/patient-year for onx and 2.1%/patient-year for sjm, mean inr was 1.7 in patients presenting with thrombosis 3.No embolic events in either group 4.Postop bleeding= 2.7% for onx and 3.8% for sjm 5.Neurologic insults occurred in 1.6% of onx and 1.1% of sjm group 6.2 onx patients had endocarditis 7.Hemodynamics appeared similar but numerically better for onx valves.8.Eoai was higher in onx group (1.1 cm2/m2) thn sjm (1.0 cm2/m2) with p = 0.034 a.This was most significant in small sized valves 25mm- 1.09 cm2/m2 for onx compared to 0.93 cm2/m2 for sjm, p=0.02.9.Incidence of patient prosthesis mismatch was less in onx, but not statistically significant.A.No ppm: 43% onx and 35% sjm b.Moderate ppm: 55% onx and 64% sjm c.Severe ppm: 2% onx and 1% sjm.Additionally, the publication states, "though we noted valvular thrombotic events due to subtherapeutic inr, there were no embolic events in both groups" and "all hospital mortalities were not valve related.".

• Brand Name: ON-X MITRAL VALVE UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES-AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd.; kennesaw, GA 30144
• MDR Report Key: 7034510
• MDR Text Key: 92111681
• Report Number: 1649833-2017-00084
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXM UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/18/2017
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Other