Medwatch report #: mw5150926 received regarding a 25mm trifecta bioprosthetic aortic valve experienced episodes of dizziness, chest pain, arm pain, shortness of breath, lethargic, unable to lie down.It passed.Then, happened again a few days later and was taken to er.Sent home the same day.Worsening episodes to include belching, and not hungry.Returned to hospital (b)(6) 2024.Diagnosed (b) (6) 2024 with severe prosthesis stenosis of a st.Jude trifecta bioprosthetic aortic valve.Patient was transferred to (b)(6) and is awaiting possible tavr procedure currently.It was reported that on 26 august 2016, a 25mm trifecta valve was implanted.On (b)(6) 2023, the patient experienced episodes of dizziness, angina, arm pain, dyspnea, lethargy, unable to lie down.The symptoms eventually passed but then came back a few days later so the patient was taken to the emergency room.The patient returned home the same day.Symptoms began to then include belching and reduced appetite.On (b)(6) 2024, the patient was hospitalized and diagnosed with severe aortic stenosis.Patient was transferred and is awaiting possible intervention.
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An event of severe aortic stenosis was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on received information, the cause of reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Attachment medwatch report #: mw5150926.
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