A medwatch email was received on 30 august 2023, reporting the incident with e100-25m-00 and tfgt-21a.It was reported that a 25mm stented porcine,mit,epic 25mm-00 and 21mm trifecta gt final package - wr was implanted in a patient on (b)(6) 2018.On an unknown date and year, the patient was hospitalized requiring increase in medication due to heart failure.A transesophageal echocardiogram (tee) results showed aortic valve: bioprosthetic aortic valve present.Leaflets are mobile, there was moderate transvalve aortic regurgitation.The di is 0.41.At is 92ms.The mg is 28mmh mitral valve well seated, no stenosis or regurgitation.Tee reveals normal right ventricular/left ventricular function and normal wash out jet.No paravalvular leak (pvl).The bioprosthetic trifecta aortic valve has mild degeneration changes with no stenosis, however has moderate aortic regurgitation and also patient prosthesis present.Need to switch to coumadin due to valvular atrial fibrillation (af), with local cardiologist.Potential mismatch of the device.Patient status is unknown reference report: mw5120624.
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An event of moderate aortic regurgitation and valvular atrial fibrillation (af) was reported.It was also reported that the trifecta aortic valve had mild degeneration changes with no stenosis.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.No implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.Biological factors as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.), immobilizing thrombus, or pannus formation reducing the valve diameter also could not be confirmed as the valve was not returned for histopathological examination.Based on the information received, the cause of the reported incident could not be conclusively determined.
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