The manufacturing records for the onxace-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.During the investigation no non-conformances or deviations were noted.Change order(s) for leaflet tuning are performed as a part of the standard manufacturing process.On (b)(6) 2023 an onxace-21 sn (b)(6) was used in a case for a 63-year-old female in the aortic position.A second aortic on-x was reported to device tracking on (b)(6) 2023 as implanted in the same position, same patient: (b)(6) 2023 onxace-21 sn (b)(6) (150 days post-implant).Additional information was obtained from the surgeon; however, the valve was not returned for inspection.The statement from the surgeon is as follows "i explanted the valve so i could do a redo avr/mvr for mitral valve endocarditis (culture negative).I put another on-x back in the aortic position and put an on-x mechanical in the mitral.The old dehisced valve was a st.Jude.There was nothing wrong with the on-x aortic valve.I just took it out for exposure purposes, and i could not say that it was not infected.It looked perfect and it was functioning perfectly too.Valve was not saved.Patient is doing great." review of manufacturing records show no processing issues with the original valve and with the statement from the surgeon we can say that the on-x aortic valve itself did not contribute to the explantation.The valve was explanted during an avr/mvr redo secondary to mitral valve endocarditis and the surgeon could not definitively state there was no infection of the aortic valve when it was removed to facilitate the replacement of the infected mitral valve.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.
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