MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH STANDARD SEWING RING AND EXTENDED HOLDER; HEART VALVE, MECHANICAL

Model Number	ONXAE-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
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 medwatch form received via email from the fda medical device reporting team on 02/11/2026, ¿describe the event or problem: after securing the cor-knots, the surgeon attempted to cut out the valve holder, however it did not dislodge.The suture of the valve holder was cut and handle was removed, but valve would still not come out.There was concern the valve had become damaged when trying to remove the holder.A sternotomy was performed and the valve was removed and replaced with a different valve.What was the original intended procedure? : minimally invasive aortic valve replacement, using right mini thoracotomy approach what problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working)¿.Fda medwatch form 3500a medsun report number: (b)(4).
Additional Manufacturer Narrative
The manufacturing records onxae-21, 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.The available information was reviewed.According to the medwatch form received via email from the fda medical device reporting team on 11feb2026, the reported event stated that after securing the cor-knots, the surgeon attempted to cut out the valve holder; however, it did not dislodge.The suture of the valve holder was cut and the handle was removed, but the valve still would not come out.There was concern that the valve had become damaged during the attempt to remove the holder.A sternotomy was performed and the valve was removed and replaced with a different valve.The original intended procedure was a minimally invasive aortic valve replacement using a right mini thoracotomy approach.The problem reported by the user was that the device failed, specifically that the valve would not dislodge from the valve holder.This investigation pertains to onxae-21, serial number (b)(6), with the allegation that the valve would not dislodge from the valve holder.The fda medwatch report number associated with this event is 4500440000-2026-8014.Additional information was received from the field representative on 11feb2026.The representative stated that the surgeon placed all sutures before attempting to remove the handle, and that the expected process is to place the three nader stitches and then remove the handle.It was also reported that the valve was not saved and was disposed of after the case.The patient was reportedly doing well post-operatively.Based on the available information, the reported event is most consistent with use error.The field representative reported that the surgeon placed all sutures before attempting to remove the handle, whereas the handle should be removed after placement of the three nader stitches.This sequence may have prevented proper removal of the holder and contributed to the need to replace the valve.Because the device was not returned and no product evaluation could be performed, a manufacturing or device-related issue could not be confirmed.Based on the information available, the most likely root cause is procedural or surgeon technique rather than product malfunction.No further physical evaluation could be completed because the valve was disposed of after the case.Based on the information received, no device-related corrective action was identified, and the event was attributed to surgeon error.The surgeon has received further education from the representative after this occurrence.Based on the available information, the reported event is most consistent with use error.The valve was not returned so no direct observation could be made.The manufacturing records were reviewed and all lots passed functional testing and met release specifications.This event does not identify additional hazards or modify the probability and severity of existing hazards, 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 AORTIC VALVE WITH STANDARD SEWING RING AND EXTENDED HOLDER
• 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: 24544121
• Report Number: 1649833-2026-00008
• Device Sequence Number: 18512933
• Product Code: LWQ
• UDI-Device Identifier: 00851788001396
• UDI-Public: 00851788001396
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: ONXAE-21
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown