Current methods utilized for safety surveillance of medical devices rely primarily upon voluntary reporting of adverse events by health care providers and institutions to manufacturers and to the FDA. This system has been criticized for its dependence on voluntary reporting and the inability to accurately ascertain both incident and prevalence rates of specific adverse events. The emerging availability of mandatory detailed clinical outcomes registries, such as the Mass-DAC datasets, may provide extremely useful complementary data for procedural and medical device safety surveillance. The objective of this study is to evaluate whether automated safety monitoring systems can detect deviations from expected clinical outcomes for a variety of cardiovascular revascularization procedures with acceptable accuracy and discrimination. Dr. Frederic Resnic from Brigham and Women’s hospital has adapted a number of statistical methodologies in order to conduct risk-adjusted outcomes monitoring for prospective cohorts, particularly of mandatory registries. These methods have been incorporated into an automated computer application with a web interface to allow administration of the system. Working with Dr. Resnic, Dr. Normand will explore a number of outcomes (drug-eluting stent mortality, vascular closure device usage and complications; embolic protection device and MI) to determine at what time point (if at all) the automated system will detect adverse events or hospital-specific deviation from expected outcomes.