FOI release

Freedom of Information request on Heartware LVADs (FOI 21/1048)

Published 27 April 2022

5th October 2021

FOI 21/1048

Dear

Thank you for your information request, dated 13/9/21.

The MHRA is aware of Medtronic’s decision to stop the distribution and sale of the HeartWare Ventricular Assist Devices (HVAD) System. Patient safety is our highest priority. The MHRA has been assured by Medtronic that UK patients implanted with HVAD will continue to receive clinical support and replacement components will be provided when required. The MHRA has also obtained reassurance from Abbott that alternative devices will be available to UK patients. Any patients who are concerned should contact their clinic for further advice. We will continue to actively monitor the situation and people are encouraged to report any adverse incidents via our Yellow Card scheme.

The questions in your information request are:

1. How many adverse reactions have been reported in relation to these devices (Heartware LVADs, a type of mechanical heart pump) since 2007?

2. How many deaths have been reported as potentially being linked to Heartware devices?
3. More info on the nature of the complaints received. There have been various issues with them (Heartware LVADs, a type of mechanical heart pump), such as battery failure and issues with power connectors.
4. When were Heartware devices first given approval for use in the UK? I believe they were first used here in 2007.
5. Was there a formal process that would have led to this? (approval for use in the UK)

Unfortunately, the information that you’ve requested in questions 1, 2, and 3 is exempt from release under section 44 of the Freedom of Information (FOI) Act due to Prohibitions on Disclosure.

Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested:

• constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.

• relates to the affairs of Medtronic, a business which continues to exist.

On that basis we are satisfied that section 44 of FOI Act applies, and the information is exempt from release.

I can also confirm that we do not hold the information that you have requested in question 4; for further background on how medical devices are regulated, see our answer to question 5.

I am pleased to provide the following answer to question 5:

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulator for medical devices and medicines. One of MHRA’s roles is to apply the regulatory framework to ensure that medical devices placed on the UK market, when used correctly, will work properly and are acceptably safe.

MHRA activities to achieve this include:

• post-market surveillance, including compliance and enforcement activities.

• designating and auditing UK conformity assessment bodies (known from 1 January 2021 as UK Approved Bodies), which are independent, third-party organisations that carry out the assessments to check that manufacturers and their medical devices meet the requirements set out in the Medical Devices Regulations. The MHRA does not certify, approve or license medical devices. Prior to placing a medical device on the market in the UK, it must have a valid CE mark confirming the compliance with relevant medical device legislation. For devices such as ventricular assist devices (VADs), confirmation that the product meets relevant regulatory requirements is undertaken by one of these external Conformity Assessment Bodies. Further information on the regulation of medical devices in the UK can be found on the MHRA website: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

If you have a query about this, please reply to this email.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected]. Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices. Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU