Abstract

New York, NY;Phoenix, Ariz; Houston, Tex; London, Ontario, Canada; Delhi, India; Silver Spring, Md; and Lewiston, MeAdverse event reporting after medical device implanta-tion is essential to understanding the safety and perfor-mance of a device. Standardization of reporting attainsgreat importance when comparing different devices andfor the ongoing surveillance of a marketed device.Although some work has been done to standardize adverseevent reporting for medical devices, a single reference withrecommendations that span investigational and postmarketuse does not exist.Standardization of nomenclature for reporting vascularconditions is one of the objectives of the Society forVascular Surgery (SVS) in its Bylaws.

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