China NMPA Product Recall - Mosaic porcine bioprosthetic valve system

Medtronic, Inc., through its distributor Medtronic (Shanghai) Management Co., Ltd., initiated a global voluntary recall of its Mosaic Porcine Biological Valve Prosthesis System (SFDA (I) 20063460997) on January 21, 2014, which was reported to China's National Medical Products Administration (NMPA) on January 26, 2014. The recall stems from a risk of excessive transvalvular pressure gradient in patients. Medtronic's investigation revealed that the existing sizing tables (Intended Effective Orifice Area - iEOA index tables) and measuring devices for the Mosaic valve might lead to the selection of an oversized valve. This can cause abnormal leaflet movement and impaired valve function, as observed in three cases involving size or shape mismatches.

To address this critical issue, Medtronic is undertaking several corrective actions. These include revising the iEOA Mosaic porcine bioprosthetic valve sizing table and improving the current obturator/valve measuring device, along with updating its Instructions for Use to incorporate the new sizing chart. Furthermore, Medtronic will cease the sale of the previous sizing chart and measuring device. The company will also notify healthcare facilities that procured these valves within the last three years and provide comprehensive training to all physicians involved in Mosaic valve implantations, educating them on the updated recommendations for accurate valve measurement.