FDA EIR - Thoratec LLC - November 23, 2015

An FDA inspection of Thoratec Corporation, manufacturer of the HeartMate II Left Ventricular Assist Device (LVAD), was conducted from November 10-23, 2015. This 'for cause' inspection, following up on previous observations and current field corrective actions, revealed significant issues. The regulatory framework for this inspection falls under the FDA's Compliance Program Guidance Manual 7382.845 for medical device manufacturers, specifically for Class III devices. Main violations included an inadequate design validation for the HeartMate II LVAD system, failing to address the critical risk of power loss during system controller exchanges. This oversight was directly linked to adverse events and patient deaths. Furthermore, the firm's risk analysis was deemed insufficient, particularly regarding the mitigation of power loss risks and inconsistent probability calculations for associated hazards based on reported complaints. A recurring issue was the lack of adequately established procedures for identifying valid statistical techniques, specifically observed in the unjustified sample size and composition of human factors studies used for device validation. Management received a Form FDA 483, Inspectional Observations, detailing these deficiencies, and confirmed they were under consideration, committing to a written response. The inspection highlighted a need for robust statistical rationale in validation activities and a comprehensive re-evaluation of device risks, especially concerning user-initiated actions and associated patient safety.