Potential risk of valve infolding for the Medtronic Evolut™ PRO+ 34mm Transcatheter Aortic Valve

A Dear Healthcare Professional Letter has been issued by Medtronic International, Ltd. to inform healthcare professionals of a potential risk of infolding of the Medtronic Evolut™ PRO+ 34mm Transcatheter Aortic Valve. Valve infolding may result in serious adverse events, including unplanned surgery or intervention. Medtronic will be updating the affected device's Instructions for Use to include instructions for the detection of infolded valves, removal and replacement of infolded valves, and pre-dilatation of the implantation site to mitigate the risk of valve infolding. Healthcare professionals are advised to review the updated instructions provided in the letter and to continue to manage patients who have been treated with an Evolut™ PRO+ TAV according to standard patient management protocols. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

9 Dec 2022

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

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.