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

Model Number	ONXACE-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Myocardial Infarction (1969)
Date of Event	03/31/2025
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- formerly cryolife/jotec is accurate or has been confirmed by artivion.
Event or Problem Description
According to the report, the patient's pre-op diagnosis was nstemi (non-st-elevation myocardial infarction), chest pain.The device was explanted due to endocarditis with large annular abscess.
Additional Manufacturer Narrative
A sample evaluation was not performed as the device was not released for return.The 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.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.The on-x aortic device was implanted on (b)(6) 2024 in a 42-year-old male.A second on-x aortic device was reported via device tracking as implanted in the same position, same patient: (b)(6) 2025 onxace 21 sn (b)(6) (439 days post implant).Additional information was received from the operating surgeon regarding the explantation procedure.The explant was performed due to endocarditis associated with a large annular abscess.A limited procedure note provided by the surgical team described the following interventions: redo sternotomy, removal of the infected aortic valve, drainage of an extensive circumferential intracardiac abscess, which resulted in dehiscence of the aortic annulus from the myocardium, septal myectomy with right ventricular outflow tract (rvot) resection, replacement of the mitral valve anterior leaflet with a bovine pericardial patch, circumferential patch repair of the aortic annulus, ligation of the right coronary ostium, redo aortic valve replacement, coronary artery bypass grafting (cabg) x1.The surgeon reported that the patient was recovering well as of the date of the update.Because the on-x valve manufacturing process includes a validated terminal sterilization step prior to distribution¿verified by a review of manufacturing records unique to this valve¿the valve is unlikely to be the source of infection.The instructions for use (ifu) for the on-x valve states that reoperation, including explantation, may result from a complication, in this case, endocarditis, a known potential event acknowledged in the ifu.Though rare, historically, endocarditis occurs at a rate of (b)(4) /patient-year for mechanical aortic heart valves [iso 5840-2:2021].Endocarditis was identified as the root cause for the explantation of the aortic on-x valve by the explanting surgeon.However, due to the limited information provided, the precise origin of the endocarditis could not be determined.A review of the manufacturing records confirmed that the on-x valve underwent a validated terminal sterilization step prior to distribution.Based on this confirmation, the valve is considered unlikely to have been the source of the infection.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- formerly cryolife/jotec 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.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 22125051
• Report Number: 1649833-2025-00018
• Device Sequence Number: 15620583
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 851788001464
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 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: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2023
• 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: Other
• Patient Age: 43 YR
• Patient Sex: Male