As reported in a research article, calcification was found on the valve about 5 years after the trifecta valve was implanted.The patient passed away due to sepsis one year after the calcified valve was found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications a more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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The abstract article, "trifecta bioprostheses: evaluation of the safety based on the study of degenerations according to the varc-3 classification", was reviewed.The research article is a retrospective single center experience to evaluate the intrinsic imputability of trifecta for dysfunction according to the varc-3 classification in patients implanted and to reassess their referencing in our center.Trifecta valve was the device associated with this study.The article concluded, the classification of failures according to varc-3 indicated the intrinsic imputability of the trifecta¿ bioprostheses regarding to the number of svd-type dysfunctions.Although this study has limitations, it shows the understatement of medical-devices-vigilance cases by the medical staff.[the primary author of this article is richez, ophelie, amiens-picardie university hospital, 1 rond-point du professeur christian cabrol, 80054 amiens, france, with email address of : richez.Ophelie@chu-amiens.Fr].It was reported that on an unknown date in january of 2013, a 21mm trifecta valve was implanted in a 62 year-old patient with calcified aortic stenosis.On 30 april 2018 an ultrasound showed vg 50 mm, diffuse hypokinesia, ejection fraction (ef) of 30%, calcified aortic bioprosthesis, no mitral leak, moderately impaired right ventricle function, and dry pericardium.It was reported that on 28 april 2019, the patient passed away due to sepsis in a bedridden patient with discovery of a tumoral lesion exteriorized by the urinary meatus no additional information was provided.
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