It was reported that on (b)(6) 2012, a 27mm epic valve was successfully implanted in a patient.On an unknown date, moderate mitral valve regurgitation and mitral valve stenosis was confirmed during follow-up.On (b)(6) 2023, device was explanted and and an unknown epic valve was implanted as a replacement and the surgery was completed.The patient is stable, no additional information was provided.
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Explant due to mitral valve regurgitation and mitral valve stenosis was reported.The investigation found leaflet 1 was torn.There were degenerative changes on all leaflets.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tear could not be conclusively determined; however, the degenerative changes noted to the tissue could have contributed to the tear formation.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did demonstrate loss of collagen at the tear site, which could have contributed to the formation of the tear.H6 medical device problem code: code 1153 was removed.
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