Reporting Adverse Incidents Related to Transcatheter Aortic Valves
20th March 2024
Reporting Adverse Incidents Related to Transcatheter Aortic Valves
We would like to remind all BCIS members of the importance of appropriate reporting of any adverse incidents during TAVI procedures that may be device-related.
The primary reporting route should be through the MHRA Yellow Card scheme, which is now electronic, and accessible through the link https://yellowcard.mhra.gov.uk.
In addition, we are pleased to inform members that through the work of the Structural Device Working Group, new transcatheter aortic valve technologies will be available to NHS centres in England through a limited roll-out scheme. This will allow access to named new valves in up to 10 centres in England, for an initial 12-month period. At the end of this period, the experience with those valves, based on UK TAVI Registry data, will be reviewed by NHS England and the DWG to determine future access. For those valves in this preliminary roll-out phase, which currently include Hydra, JenaValve Trilogy, and Meril Octacor, adverse incidents should additionally be reported directly to NHS England Specialised Service Devices Programme at the following e-mail address: england.ssdp@nhs.net.
Finally, we would like to emphasise the importance of accurate and complete entry to the NICOR UK TAVI Registry.
Kind regards,
Professor Dan Blackman, BCIS Structural Group Lead
Professor Adrian Banning, Structural DWG Chair
Professor Dave Hildick-Smith, BCIS President

