MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE WITH STANDARD SEWING RING (ONXM); HEART VALVE, MECHANICAL

Model Number	ONXM-25
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial notification, "on-x aortic leaflet not functioning and question regarding the sizer handle." additional information received 08/11/2025: is there an allegation of deficiency with the onx valve? on tee post op it appeared one of the leaflets was wide open has any additional imaging been performed post operatively that shows the leaflet is moving as intended? can that be shared? unsure as the patient then had a tavr when in cath lab please provide a brief medical/surgical history of the patient.On (b)(6) patient arrived for a maze and aortic valve procedure which was completed.Unable to wean patient from pump and left ventricle was not moving.Patient then had a lima to lad and an svg to the om.Still unable to wean from pump and left ventricle still was not functioning.Patient taken to cath lab and placed on ecmo.This is when it was discovered the leaflet was not functioning properly.At this time, a tavr was performed.Patient returned to surgery again that (b)(6) twice and then again on (b)(6).Patient removed from ecmo (b)(6).How is the patient doing post-operatively? patient remains in icu, is still intubated, on levophed, in atrial flutter.Additional information received 08/12/2025: model: onxm-25, sn (b)(6).Additional information received 08/15/2025: was the onxm-25 placed in the aortic position? yes.During the surgery where tavr was performed on (b)(6) and/or (b)(6), was the onxm-25 explanted? it was performed on (b)(6), same day as initial implant of the onxm-25 and no it was not explanted.
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
Op notes requested but not received.No additional information forthcoming.The manufacturing records for onxm-25, sn (b)(6) were reviewed.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 found.The available information was reviewed.On 29jul2025 an initial report was received that an aortic valve had one leaflet not functioning after implant, and a case was opened.Onxm- 25 sn (b)(6) was implanted on (b)(6) 2025 in a 62-year-old male patient in the aortic position and an allegation has been made that one of the leaflets was not functioning after the implant.Additional information was received on multiple dates from the hospital staff.On 11aug2025: in an email from the hospital, the following information was provided: the model and device information ¿model# -ach250, lot #-124686, implant id#- device occl clp l50mm plung grp flx shft for gillinov - log16534820¿ that was recognized as not an on-x model or sn and further clarification was requested.The other information provided was, ¿on tee post op it appeared one of the leaflets was wide open¿ and a brief operative history ¿on (b)(6) patient arrived for a maze and aortic valve procedure which was completed.Unable to wean patient from pump and left ventricle was not moving.Patient then had a lima to lad and an svg to the om.Still unable to wean from pump and left ventricle still was not functioning.Patient taken to cath lab and placed on ecmo.This is when it was discovered the leaflet was not functioning properly.At this time, a tavr was performed.Patient returned to surgery again that (b)(6) twice and then again on (b)(6).Patient removed from ecmo (b)(6).¿ they did confirm the valve sn (b)(6) is correct and committed to providing a copy of the medical records at this time as well.The hospital staff was asked to confirm if the mitral valve was intended to be placed in the aortic position and on (b)(6) 2025 she committed to ¿look into this¿.As of the date of this report no medical records or further clarification were received from the hospital where this event occurred.The valve was not explanted and therefore not returned for testing and inspection.A review of the processing records shows no processing issues, and the part passed all inspections and met all requirements and specification prior to shipment.As no medical records were provided there is insufficient information to point to a probable cause of the leaflet immobility, whether it be a mitral valve implanted in the aortic position, mechanical malfunction, patient anatomy, implanting technique, or a combination.Consequently, there is, at present, insufficient information to know for certain what, if any, relationship the valve has to complaint of alleged structural dysfunction.The instructions for use [ifu] for the on-x valve acknowledge reoperation as potential consequences of a complication following prosthetic valve replacement, in this case possible structural or non-structural dysfunction of unknown origin.Both are listed in the ifu.The root cause of the alleged structural dysfunction cannot be determined with the limited information provided and as such a determination cannot be made if the valve itself contributed or other causes such as a mitral valve implanted in the aortic position, patient anatomy, implanting technique or a combination of these factors contributed.No further action is required without additional information.As no medical records were provided there is insufficient information to point to a probable cause of the leaflet immobility, whether it be a mitral valve implanted in the aortic position, mechanical malfunction, patient anatomy, implanting technique, or a combination.Consequently, there is, at present, insufficient information to know for certain what, if any, relationship the valve has to complaint of alleged structural dysfunction.Manufacturing records were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion- formerly cryolife/jotec and the ifu adequately communicates risk.Artivion will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.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.

• Brand Name: ON-X PROSTHETIC MITRAL VALVE WITH STANDARD SEWING RING (ONXM)
• 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: 22945984
• Report Number: 1649833-2025-00031
• Device Sequence Number: 9257611
• Product Code: LWQ
• UDI-Device Identifier: 00851788001273
• UDI-Public: 00851788001273
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: ONXM-25
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown