Medtronic received information via literature regarding a retrospective comparison of outcomes of patients undergoing a tricuspid valve replacement with a bioprosthetic or mechanical valve, with or without a concomitant surgery on the left side of the heart.All data were collected from two centers between january 1999 and december 2018.The study population included 338 patients (predominantly female, mean age 41.3 years), 7 of whom were implanted with medtronic mechanical valve (unique device identifier numbers not provided).Among all patients, 9 deaths occurred within 30 days of implant due to cardiac failure related to severe depression of myocardial function.Throughout the follow-up period, 91 other patients died due to cardiac reasons (58 patients), low cardiac output syndrome (21 patients), valve-related complications (37 patients), and non-cardiac reasons (33 patients).Multiple manufacturer¿s devices were implanted in the study population, and no association was made between the deaths and a specific manufacturer¿s devices.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: right-sided heart failure, liver failure, renal failure, infection, bleeding, complete heart block requiring a permanent pacemaker, cerebrovascular accident, pulmonary hypertension, thrombosis, structural valve deterioration, severe tricuspid regurgitation, pannus formation, endocarditis.Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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