Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data

We demonstrated that natural language processing technology sorted through raw MAUDE data, allowing identification of the most common events associated with TAVR and Mitraclip procedures, and that MAUDE-derived event rates were not statistically significantly different from TVT event rates. This technology has important public health implications because it improves postmarket surveillance of implantable devices and permits rapid and early dissemination of vital information.