Sizing of Medtronic Mosaic™ Aortic Bioprosthesis: Important Medical Device Information, Model Number: 305

Medtronic International, Ltd. (Medtronic) would like to provide healthcare professionals with important information regarding the sizing of the Medtronic Mosaic™ Porcine Aortic Bioprosthesis. Medtronic is issuing this letter, as post-implant reports of higher-than-expected transvalvular gradients have been received, with a subset of these valves explanted within five years of implantation. Medtronic has determined that the practice of substantial oversizing can lead to cases of higher-than-expected transvalvular gradients and concluded that the current Mosaic Aortic Bioprosthesis sizing chart (indexed effective orifice area (iEOA) chart) and Obturators/Sizers may contribute in some cases to the selection of a larger than optimal Mosaic Aortic Bioprosthesis. As such, Medtronic is seeking regulatory approval to modify the iEOA sizing chart, the current Mosaic Obturators/Sizers and the Instructions for Use. Medtronic has advised healthcare professionals to remain diligent in selecting the appropriate size of Mosaic Aortic Bioprosthesis until they receive the modified Mosaic Obturators/Sizers and iEOA sizing chart. Healthcare professionals are advised to refer to the letter for more details.  Published: 23 May 2014

Dear Healthcare Professional Letters