MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

Model Number	ONXMC-25/33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
According to the initial report, "on (b)(6) 2023, the patient underwent mitral valve replacement due to mitral stenosis.One month later, mitral valve dysfunction and valve obstruction occurred.On (b)(6), 2023, an emergency operation was performed to replace the mechanical valve again.During the operation, a large number of thrombi were found in the atrium and accumulated on the valve.It was considered that the patient's hypercoagulable constitution led to the valve obstruction.".
Additional Manufacturer Narrative
The manufacturing records for onxmc-25/33 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.During the investigation no non- conformances or deviations were noted to be related to this reported event.On (b)(6)2024 an adverse event was reported in the nmpa (national medical products administration) system by the [hospital] regarding a mitral valve that was explanted and replaced due to dysfunction and obstruction.An investigation was started, and the following translated statement was obtained "on (b)(6) 2023, the patient underwent mitral valve replacement due to mitral stenosis.One month later, mitral valve dysfunction and valve obstruction occurred.On (b)(6) 2023, an emergency operation was performed to replace the mechanical valve again.During the operation, a large number of thrombi were found in the atrium and accumulated on the valve.It was considered that the patient's hypercoagulable constitution led to the valve obstruction." thrombosis 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 was given as the patient¿s hypercoagulable constitution; however, this could not be confirmed as no medical records or lab results were provided.As such, we are unable to determine what, if any, contribution the valve had to the decision to explant.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.References: iso 5840-2:2021 (e) cardiovascular implants - cardiac valve prostheses, annex i.On-x instructions for use including aortic valve inr 1.5-2.0 update.Http://www.Onxlti.Com/ifu.
Event or Problem Description
According to the initial report, "on (b)(6) 2023, the patient underwent mitral valve replacement due to mitral stenosis.One month later, mitral valve dysfunction and valve obstruction occurred.On (b)(6) 2023, an emergency operation was performed to replace the mechanical valve again.During the operation, a large number of thrombi were found in the atrium and accumulated on the valve.It was considered that the patient's hypercoagulable constitution led to the valve obstruction.".

• Brand Name: ONX MITRAL CONFORM 25/33
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 east anderson lane; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC; 1300 east anderson lane; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 21068791
• Report Number: 1649833-2025-00075
• Device Sequence Number: 15546872
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 00851788001303
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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 Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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