On (b)(6) 2015, an aortic valve replacement (avr) was performed and this 25 mm trifecta valve was implanted.Reportedly, the patient's native aortic valve was a congenital bicuspid valve which had raphe on a right coronary cusp (rcc) and a left coronary cusp (lcc).Concomitantly, ascending aortic replacement was performed and a 28 mm j graft (japan lifeline, type straight) was implanted.On (b)(6) 2017, the patient's cardiac function was confirmed to be normal through an echocardiogram with ef of 62% and peak velocity in aortic position of 2.6 m/s.No perivalvular leakage (pvl) was observed.At that time, grade ii of moderate tricuspid regurgitation (tr) was only noted with pressure gradient of 32 mmhg.On (b)(6) 2017, the patient visited to the local clinic.He was treated with administration of antibiotic (zithromax) and supportive measures due to the common cold.On (b)(6) 2017, the patient experienced chest tightness.On (b)(6) 2017, the patient's chest tightness became worse and he presented to emergency room.The patient was hospitalized with congestive heart failure (chf).An ultrasonic cardiogram (ucg) was performed and severe aortic regurgitation (ar) was revealed.Furthermore, a transesophageal echocardiography (tee) revealed that a leaflet became prolapsed to the left ventricular side.Due to acute ar caused by prosthetic valve failure and prolapsed leaflet, the surgical intervention was scheduled.On (b)(6) 2017, re-do avr was performed and this valve was explanted.Upon explant of this valve, a tear was exhibited at the commissure between lcc and rcc toward the nadir of lcc.There was no pannus formation, calcification or evidence of infective endocarditis (ie) observed on the valve.Subsequently, a 23 mm mosaic tissue valve (medtronic) was implanted.The patient remains in unstable condition.Patient identifier and weight are not available due to privacy laws.
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Product: events of ¿severe aortic regurgitation, leaflet becoming prolapsed and a tear¿ were reported.The results of this investigation concluded a tear in the base of leaflet 1.There was fibrous pannus ingrowth on the inflow surface, which narrowed the inflow diameter of leaflets 1 and 3.No acute inflammation or significant calcifications were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported events remain unknown.
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