FDA 483 - Medtronic Heart Valves Division - October 26, 2020

Medtronic Heart Valves Division in Santa Ana, CA, was cited for significant deficiencies in its complaint handling and corrective and preventive action (CAPA) procedures for Avalus Bioprosthesis valves. The firm failed to adequately investigate complaints related to valve sizing issues, used inconsistent measurement methods, and did not properly review Device History Records. Furthermore, the company did not initiate CAPA despite recurring sizing errors exceeding internal trending triggers, which in some instances led to patient explants and deaths.