MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHANICAL

Model Number	ONXACE-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/12/2024
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 received, case was on (b)(6)2024 and was uneventful.I was not in attendance.Today, while explanting the valve, the surgeon did say she noticed at the time of the initial surgery, one of the leaflets was not opening and closing freely.To my knowledge, it¿s unknown what adjustments were made to ensure leaflets moved freely.Patient subsequently reported suffering from breathing related difficulties.The onx was explanted and a st.Jude valve was implanted.I am hoping to spend some time with the surgeon to gather additional details.Per the hospital staff it sounds like the surgeon should/could have removed some tissue that was in the way of the leaflet and prevented it from moving.This investigation is relegated to onxace-23 serial number: (b)(6) with the allegation of explant due to leaflets not opening and closing freely.
Additional Manufacturer Narrative
This investigation is relegated to onxace-23 serial number: (b)(6) with the allegation of explant due to leaflets not opening and closing freely.The manufacturing records for onxane-23 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.Change order(s) for leaflet tuning are performed as a part of the standard manufacturing process.On 09jan2025, an initial report was received that during an explant procedure for an on-x valve, the "surgeon did say she noticed at the time of the initial surgery, one of the leaflets was not opening and closing freely," and a case was opened.The valve was implanted on (b)(6) 2024 in a patient of unknown gender and age in the aortic position and explanted on (b)(6) 2025 (28 days post-implant), with the allegation that one of the valve leaflets was not functioning properly.The statement from the representative is as follows: ¿case was on (b)(6) 2024 and was uneventful.I was not in attendance.Today, while explanting the valve, the surgeon did say she noticed at the time of the initial surgery, one of the leaflets was not opening and closing freely.To my knowledge, it¿s unknown what adjustments were made to ensure leaflets moved freely.Patient subsequently reported suffering from breathing related difficulties.The on-x was explanted, and a st.Jude valve was implanted.¿ the valve was returned to the manufacturer for evaluation; however, no medical records nor a statement from the surgeon were provided.As such, there is limited information to point to a probable cause of the leaflet immobility, whether it be mechanical malfunction, patient anatomy, implanting technique, or a combination of factors.We were able to rule out mechanical malfunction, as the sample evaluation summary states: ¿the valve was put through artivion¿ s subassembly process again and no deficiencies related to leaflet mobility were noted.This point towards possible geometric interference of the leaflets.¿ a review of the processing records shows no processing issues, and the part passed all inspections and met all requirements and specifications prior to shipment.Consequently, there is, at present, insufficient information to know for certain what, if any, relationship the valve has to the decision to explant.The instructions for use (ifu) for the on-x valve acknowledge reoperation and explantation as potential consequences of complications following prosthetic valve replacement¿in this case, possible non-structural dysfunction of unknown origin.Alleged structural dysfunction was the reason for explant, and with the limited information provided, the only root cause that can be effectively ruled out is that of mechanical malfunction or structural device deficiency.With the information provided by engineering, it is unlikely a device deficiency occurred that resulted in improperly functioning leaflets.We have no way to assess the other possible root causes such as patient anatomy and implantation technique.A root cause for a product failure mode cannot be determined; thus, severity and occurrence are not evaluated.Alleged structural dysfunction was the reason for explant, and with the limited information provided, the only root cause that can be effectively ruled out is that of mechanical malfunction or structural device deficiency.With the information provided by engineering, it is unlikely a device deficiency occurred that resulted in improperly functioning leaflets.We have no way to assess the other possible root causes such as patient anatomy and implantation technique.No further action is required without additional information.There is no indication that an error or deficiency occurred at artivion- formerly cryolife/jotec and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Field assurance 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: ONX AORTIC CONFORM EXT 23
• 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 blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 21173369
• Report Number: 1649833-2025-00081
• Device Sequence Number: 19917546
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 00851788001464
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: ONXACE-23
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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: Required Intervention
• Patient Sex: Unknown