FDA EIR - Thoratec LLC - February 28, 2014

An FDA inspection of Thoratec Corporation, a manufacturer of the HeartMate II Left Ventricular Assist Device, was conducted from February 18-28, 2014, in Pleasanton, CA. This 'for cause' inspection followed the Compliance Program Guidance Manual 7382.845 for Medical Device Manufacturers. The inspection resulted in a two-item Form FDA 483, citing significant violations of medical device regulations. The primary issues included inadequate procedures for Corrective and Preventive Action (CAPA), specifically the failure to consistently require effectiveness verification for all CAPA activities. Examples showed CAPAs closed without root cause determination or objective evidence of effectiveness verification, despite a Class I recall related to a device component detachment. Additionally, the company's procedures for identifying valid statistical techniques for process and product characteristic verification were not adequately established or implemented, with several design validation reports lacking necessary statistical rationale for sample selection. During the inspection, Thoratec Corporation initiated a Correction and Removal Action for its HeartMate II Pocket System Controller due to a trend of complaints involving difficulties in switching controllers, which had reportedly led to patient deaths and serious adverse events. Management noted the observations were 'under consideration' and committed to taking appropriate actions, including responding to the district director within 15 business days. The FDA cautioned that uncorrected issues could result in legal sanctions such as seizure, injunctions, or civil penalties under the Food, Drug and Cosmetics Act.