Updates to IFU regarding the risk of Medtronic Evolut™ transcatheter aortic valve leaflet damage when performing a post-implant balloon dilatation

A Dear Healthcare Professional Letter has been issued by Medtronic International, Ltd. to inform healthcare professionals on the updates to the Instructions for Use (IFU) manuals for the Medtronic Evolut™ Transcatheter Aortic Valves (TAVs), specifically, regarding the risk of damage to Medtronic Evolut™ TAV leaflet damage when performing a post-implant balloon dilatation. Complaints of damage, resulting in moderate or severe aortic insufficiency, have been reported. They were detected acutely or during follow up and required re-intervention, conversion to surgery, re-intervention followed by surgery or conservative treatment. Medtronic’s investigation identified that over-expansion of the narrowest portion (waist) of the TAV can potentially cause damage to the bioprosthetic leaflets. Healthcare professionals are advised to refer to instructions on the maximum balloon diameter and maximum balloon inflation for post-implant balloon dilatation procedure listed in the letter while the Evolut™ System IFU is being updated with the relevant information. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

6 Nov 2020

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.