500.08 Adverse Events and Modes of Failure Associated with the Filterwire EZ Embolic Protection System; The Utility of the FDA MAUDE Database

Embolic protection devices (EPDs) prevent distal embolization of atherothrombotic material during percutaneous interventions resulting in reduced microvascular obstruction, improved microcirculation, and tissue perfusion. The FilterWire EZ Embolic Protection System (Boston Scientific, Natick, MA) is