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. 

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.