The manufacturer was informed on few failed mitroflow devices requiring valve-in-valve procedures.No further information provided on the device malfunction noted, implant time of the devices and outcome of the patients.The manufacturer obtained additional information identifying that one of these patients had a mitroflow valve lxa21 implanted on (b)(6) 2011.The patient¿s preoperative diagnosis was of native aortic valve stenosis.The patient tolerated the procedure well and was taken to the recovery room in critical but stable conditions.The follow up visit performed in (b)(6) 2011 confirmed a good function of the mitroflow valve implanted.The echo also showed a mild, concentric left ventricular hypertrophy (lvh) with normal ventricular systolic function and estimated ef of 55%.The echo performed in (b)(6) 2013 showed the presence of mild, concentric lvh, ef 55-60%.The mitroflow valve showed a normal functionality.No significant change is identified compared to the echo performed in (b)(6) 2011.The echo reports received for the exams performed in jan and december 2016 are not fully readable (sections related to the aortic valve are cut out).However, it is possible to identify changes in the functionality of the mitroflow valve (mild aortic regurgitation identified, not possible to confirm if aortic stenosis also present).Moderate concentric lvh, with ef ranging from 55% to 65% is also identified in both exams.The tee performed in (b)(6) 2018 showed a mitroflow valve dysfunction with a mean/peak gradient of 26/52.42mmhg (increased from previous studies).One of the leaflets is reportedly immobile.There is moderate to severe intravalvular aortic regurgitation.A normal lv systolic function is reported with ef 55-60%.The patient has been having symptoms of congestive heart failure for which the patient was medically optimized and referred for right and left heart catheterization (performed on (b)(6) 2018).On (b)(6) 2019 the patient was treated with a transcatheter aortic valve replacement with medtronic #23 evolute r valve.The preoperative diagnosis was of severe aortic valve insufficiency and aortic stenosis post aortic valve replacement with a #21 mitroflow valve.The patient was discharged on (b)(6) 2019.
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