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 found to be related to the complaint.On (b)(6) 2022, the patient underwent an aortic valve replacement with an onxaap-23 sn (b)(6).The provided medical records, after translation, give a post-operative diagnosis at the time of initial discharge of ¿endocarditis aortic about bentall mechanical, complicated with abscess¿, but no microbiology results or indication of source of infection was included.Then according to the adverse event case report form they were diagnosed with endocarditis on (b)(6) 2022 (68 days post-implant), and on (b)(6) 2022 (72 days post implant) underwent an explant surgery of the onxaap device.The explanted valve was not returned for examination, and the provided medical records with limited translation were the only records available for review.With the information provided, the source of the endocarditis is unknown.However, because all on x valves undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source of the 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 0.3 %/patient-year for mechanical aortic heart valves [iso 5840-2:2021].Endocarditis is the root cause for the explantation of the aortic valve.Because all on-x valves undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source of the infection.Each individual hazard is mitigated and reduced as far as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu (instructions for use).No new risks were identified during the course of the review.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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