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

Thursday, October 10, 2019

Submitted by

Mark Ferguson

Source

Source Name: JAMA Internal Medicine

Source URL: https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2752362

Author(s)

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.