No sample evaluation was performed as the device remains implanted.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.On (b)(6) 2022 an onxaap-23 was implanted in a 52-year-old male and on (b)(6) 2023 (323 days post implant) he was hospitalized with a diagnosis of right sided cerebellar stroke.Limited information was provided regarding the event and no medical records were provided.According to communications, the patient was discharged from the hospital on (b)(6) 2023 (1 day post incident) and is doing well.Treatment in response to the stroke was to maintain inr at 2.0-3.0.It is unknown if there were any contributing factors and the inr at the time of the incident is also unknown.The device history record concluded that the aap device passed on-x acceptance criteria prior to initial release.Thromboembolism is recognized as a potential adverse event in the instructions for use [ifu] and occurs at a historical rate of 1.6%/valve-year for mechanical aortic valves [iso 5840].With the available information, it is unknown what, if any, contribution the valve had to the occurrence of this stroke or if the patient's past medical history or inr level were contributory factors.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.
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