# China NMPA Product Recall - Mosaic porcine bioprosthetic valve system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc-usa/6c92a276-ee5c-47f2-be5e-a44b366bb04e/
Source feed: China

> China NMPA product recall for Mosaic porcine bioprosthetic valve system by Medtronic, Inc. (USA) published January 28, 2014. Recall level: . Medtronic, Inc., through its distributor Medtronic (Shanghai) Management Co., Ltd., initiated a glob

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic, Inc. of the United States has issued a recall of its Mosaic porcine bioprosthetic valve system.
- Company Name: Medtronic, Inc. (USA)
- Publication Date: 2014-01-28
- Product Name: Mosaic porcine bioprosthetic valve system
- Recall Reason: Oversized valves can cause excessive transvalvular pressure gradients. In particular, implanting a valve significantly larger than the optimal size, or implanting a valve that is actually larger than the original aortic annulus, can alter the normal leaflet movement during fluid flow, leading to a mismatch between the annulus and the size and/or shape of the Mosaic porcine bioprosthetic valve inlet. Furthermore, Medtronic has concluded that current Mosaic porcine bioprosthetic valve sizing tables (Intended Orifice Area (iEOA) index tables) and obturator/valve measuring devices may, in some cases, lead to the selection of an oversized valve rather than the optimal Mosaic porcine bioprosthetic valve.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic, Inc. (USA)
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc-usa/1bea1104-fe50-42ca-a972-f27478906219/