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.

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 ↗ (opens in new tab) 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.