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Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database
Reporting of postmarket outcomes for the Sapien 3 and Mitraclip devices frequently misclassified patient deaths as device malfunction or other outcomes. Misclassification for Sapien 3 involved 17.5% of patient deaths, and involved 24.7% of patient deaths for Mitraclip. These outcomes are important for the public and physicians to understand when discussing risks and benefits of such devices.