MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 27/29; HEART-VALVE, MECHANICAL

Model Number	ONXM-27/29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report, this onxm-27/29 sn (b)(4) was implanted on (b)(6) 2021 in which a redo procedure was performed.
Additional Manufacturer Narrative
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 is accurate or has been confirmed by artivion.
Additional Manufacturer Narrative
The manufacturing records for the onxm-27/29 serial number (sn) (b)(6) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.Onxm-27/29 sn (b)(6) was implanted in the mitral position on (b)(6) 2021 in a patient of unknown gender and age.This valve was reported as explanted on (b)(6) 2021 (192 days post-implant) due to thrombosis.The explant operative report was made available, and the valve was returned to the manufacturer for analysis.The explant operative report states that the ¿mitral valve prosthesis was found to be thrombosed.There was no evidence of pannus ingrowths¿.The returned explanted valve was examined.As received, a large tissue obstruction can be seen on both the outflow and inflow sides of the valve.This thrombus interfered with the normal operation of the leaflets, and they would not articulate.Prior to decontamination a visual examination of the valve shows the leaflet and housing intact, and no abnormalities observed with the valve assembly.After decontamination, thrombus remained but was reduced the valve was visually examined and no deficiencies were noted.There was no evidence of pannus formation.The valve failure was confirmed to be due to thrombosis and there was no sign of a defect with the valve.Without any lab data such as inr or coagulopathy results available for review, we are unable to arrive at a conclusive root cause, however the most common cause of valve thrombus in this situation is inadequate anticoagulation.Thrombus is a rare, but a known potential complication of prosthetic valve replacement occurring at a historical rate of (b)(4) per patient-year for mechanical mitral heart valves [iso 5840-2:2021 (e)].It is recognized as a potential adverse event for the on-x valve along with the potential for reoperation and explantation [ifu].The definitive root cause of the thrombosis is unknown considering the limited lab results.However, the most common case of valve thrombosis in this situation is inadequate anticoagulation and this can lead to the need for explant and replacement of the mechanical heart valve.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 is accurate or has been confirmed by artivion.
Event or Problem Description
According to the initial report, this onxm-27/29 sn (b)(6) was implanted on (b)(6) 2021 in which a redo procedure was performed.
Additional Manufacturer Narrative
This is a correction report for the following statement: the definitive root cause of the thrombosis is unknown considering the limited lab results.However, the most common cause of valve thrombosis in this situation is inadequate anticoagulation and this can lead to the need for explant and replacement of the mechanical heart valve.

• Brand Name: ONX MITRAL STANDARD 27/29
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 16146327
• Report Number: 1649833-2023-00001
• Device Sequence Number: 5846638
• Product Code: LWQ
• UDI-Device Identifier: 00851788001280
• UDI-Public: 851788001280
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2023

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 Expiration Date: 07/25/2025
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 12/13/2022
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 03/17/2023; 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown