MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT; HEART VALVE, MECHANICAL

Model Number	ONXAAP-19
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2026
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 initial notification on (b)(6) 2026, "during the aap implantation they noticed that the excess tissue that was preventing the valve leaflets from functioning properly had not been removed, so the needed to cut it, not easy to do especially in a 19 mm diameter, and it prolonged surgery by almost one hour." this investigation is relegated to onxaap-19, sn (b)(6) with allegation of excess material preventing valve leaflets from functioning properly.Additional information received from rep 02/12/2026: "i have a few more questions for the surgeon regarding this event: 1.Is this picture exactly what the surgeon was looking at in a un-altered on-x aap as it was supplied right from the box and into the patient? or.2.Did the surgeon cut the supplied valsalva graft away from the on-x size 19mm valve and then attempt to sew on a different graft? unfortunately, your first option.".
Additional Manufacturer Narrative
The manufacturing records for onxaap-19, 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 06 feb 2026, an initial report was received, and a case was opened regarding an allegation that excess tissue had not been removed from the valve area, which prevented the valve leaflets from functioning properly during implantation.Onxaap-19 sn (b)(6) was involved with the allegation of excess material preventing the valve leaflets from functioning properly.According to the initial notification on 06 feb 2026, "during the aap implantation they noticed that the excess tissue that was preventing the valve leaflets from functioning properly had not been removed, so they needed to cut it, not easy to do especially in a 19 mm diameter, and it prolonged surgery by almost one hour." as this was a translated message, it was clarified that the complaint was regarding extra graft material present in the valve and not organic tissue.Additional information received from the representative on 12 feb 2026 stated that follow-up questions were asked to the surgeon regarding whether the condition shown was observed in an unaltered on-x aap as supplied from the box and implanted into the patient, or whether the supplied valsalva graft had been cut away and a different graft had then been sewn on.The response received was that the pictures show the unaltered on-x aap device as supplied.The product was implanted and was not returned the reported patient impact was prolonged surgery.The instructions for use (ifu) for the on-x app identify structural dysfunction as a potential complication associated with implantation of the device.The reported event involved an allegation that excess material had not been removed, which interfered with valve leaflet function during implantation and reportedly prolonged surgery by almost one hour.No further action is required without additional information.A non-conformity investigation was opened into this event.On 29 april 2026, we received new information from the capa investigation.Based on process recreation and evaluation of the applicable procedures, the most probable mechanism for the observed condition is that the graft collar was not trimmed to the specified length during the graft attachment operation, resulting in excess material remaining within the conduit.Based on the amount of excess material observed in the complaint photographs and the process recreation performed during the investigation, the condition is most consistent with omission of trimming rather than insufficient trimming.The execution details on the specific complaint device cannot be definitively confirmed because the device was corrected intraoperatively and not returned for evaluation.Based on the available information, the event does not identify additional hazards beyond those evaluated, nor does it change the assessed probability or severity of existing hazards.Although the specific execution details for the complaint device could not be definitively confirmed because the device was not returned, the issue was reviewed through the capa evaluation process, and a capa was issued in response to this complaint.The ifu continues to adequately communicate the applicable risks.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 ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• 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: 24483029
• Report Number: 1649833-2026-00007
• Device Sequence Number: 18812678
• Product Code: LWQ
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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?: Yes
• Device Model Number: ONXAAP-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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