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Health Sciences Authority
Dear Healthcare Professional Letters

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

Audiences

Healthcare professional

Industry member

Product type

Medical devices

29 October 2020

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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.

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.

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