Multiple events were reported through a research article, which included paravalvular leakage, regurgitation, perforation, obstructed leaflets and a number of patient outcomes including death.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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It was reported that a study was conducted where medical records from january 2008 to december 2018 for 25 mitral valve patients, including 4 abbott mechanical heart valves, requiring reoperation were collected.The majority of mitral valve dysfunction were paravalvular leaks, open - closure dysfunction, and perforation.Two patients died of cardiac causes before reoperation (one died in the hospital due to malignant arrhythmia, the other self-discharged due to financial issues and died of heart failure after 22 days) and an unknown number of patients required blood transfusions.Post-operative complications included cardiac dysfunction, arrhythmia, sepsis, pulmonary infection, gastrointestinal bleeding, cerebral hemorrhage, chronic renal dysfunction, and surgical hemorrhage.Five (5) patients died after reoperation from cardiac dysfunction, septic shock, and self-discharge.Manufacturer report number: 2648612-2020-00032.
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