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Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database

Thursday, October 10, 2019

Submitted by



Lily Meier, Elizabeth Y. Wang, Madris Tomes, Rita F. Redberg

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. 

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