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-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial email on (b)(6) 2024, "attached you will find a new ae regarding on-x and the ascend study." source documentation states patient in the ascend study experienced cardiac arrythmia that led to hospitalization beginning on (b)(6) 2023 and resolving (b)(6) 2023.
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
No additional information forthcoming.The manufacturing records for onxaap-25, 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.The available information was reviewed.An onxaap 25 with serial number (b)(6), was implanted on (b)(6) 2023, in a 58-year-old male patient with a medical history of systemic arterial hypertension, obesity, dyslipidemia, type 2 diabetes mellitus (dm ii), chronic obstructive pulmonary disease (copd), and severe aneurysmal dilation of the aortic root (51 mm) with mild ectasia of the ascending aorta (40 mm).On (b)(6) 2023, the patient underwent aortic valve replacement with the on-x aap devise using the modified bentall technique, along with concomitant single bypass.The recovery period was complicated by the development of severe acute respiratory distress syndrome (ards), which required prolonged ventilation.On (b)(6) 2023, the patient was diagnosed with bilateral ventilator-associated pneumonia (vap) and a tracheostomy was performed on (b)(6) 2023.The patient developed acute renal failure, necessitating continuous renal replacement therapy (crrt).Additionally, the patient experienced an episode of atrial fibrillation, which was treated with amiodarone.On (b)(6) 2024, the patient was transferred to the cardiac surgery unit and ultimately discharged home.According to the adverse event (ae) report received from the site on (b)(6) 2024, the atrial fibrillation episode occurred on (b)(6) 2023, 13 days post-implantation, and resolved by the following day with treatment using amiodarone.No further episodes of atrial fibrillation occurred during the patient¿s hospitalization, and the amiodarone was discontinued prior to discharge.The instructions for use (ifu) for the device list cardiac arrhythmia as a potential adverse event for mechanical prosthetic valve recipients.There is no indication that the device contributed to the reported episode of atrial fibrillation, and it is more likely to be a complication related to the surgical procedure rather than the valve itself.The episode of atrial fibrillation is considered a probable consequence of the aortic valve replacement surgical procedure.There is no evidence to suggest that the prosthetic valve contributed to the reported arrhythmia.Regarding the pneumonia and ards, the patient's underlying medical conditions¿copd, hypertension, and obesity¿may have been contributing factors.However, the device, which undergoes validated terminal sterilization, is unlikely to be the source of the vap.No further action is required.A review of the information was performed to compile a risk analysis.The episode of atrial fibrillation is considered a probable consequence of the aortic valve replacement surgical procedure.There is no evidence to suggest that the prosthetic valve contributed to the reported arrhythmia.Regarding the pneumonia and ards, the patient's underlying medical conditions¿copd, hypertension, and obesity¿may have been contributing factors.However, the device, which undergoes validated terminal sterilization, is unlikely to be the source of the vap.A product failure mode cannot be identified; thus, severity and occurrence is not evaluated.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.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: 21035515
• Report Number: 1649833-2024-00074
• Device Sequence Number: 18272812
• Product Code: LWQ
• UDI-Device Identifier: 00851788001532
• UDI-Public: 00851788001532
• Combination Product (Y/N): N
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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 Expiration Date: 07/01/2025
• Device Model Number: ONXAAP-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: 12/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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: Other; Hospitalization
• Patient Sex: Unknown