FDA EIR - Medtronic Heart Valves Division - October 26, 2020

An FDA inspection was conducted at Medtronic Heart Valves Division in Santa Ana, CA, from October 13 to October 26, 2020. This post-market inspection focused on the Avalus Bioprosthesis Heart Valve, covering quality system elements such as design controls, corrective and preventive actions (CAPA), production controls, complaints, and supplier controls. Two significant issues were identified, leading to FDA-483 observations. First, the company failed to adequately evaluate and investigate complaints regarding potential device specification failures, a concern also noted in a previous inspection. Specifically, 140 complaints related to valve sizing errors, where implanted valves were oversized and required replacement, were not sufficiently investigated. The firm's analysis methods for returned devices were inconsistent with production inspection methods, and reviews of Device History Records for non-returned devices lacked objective evidence or failed to address documented non-conformances and reworks. Second, Medtronic's procedures for corrective and preventive actions were inadequate. The firm did not properly analyze and assess quality data from sizing error complaints to initiate appropriate CAPA, even with a high trending of these issues. The inspection was performed under compliance programs for medical device manufacturers and premarket approval/post-market inspections. Medtronic committed to correcting Observation 1 and had already revised its trending and CAPA procedures for Observation 2, though verification was pending. The company is required to submit a formal response outlining its corrective actions.