Sales of Medtronic Heartware mechanical heart pump halted

The HVAD is a mechanical heart pump which helps the left ventricle (main pumping chamber of the heart) pump blood to the rest of the body. It is used as a temporary measure for heart transplant patients at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as therapy in patients where new transplants are not planned and the ventricular device is intended as a permanent implant.

Medtronic received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was necessary.

Its advice says clinicians should immediately stop new implantation of the HVAD due to a growing body of evidence which demonstrated that the HVAD has a higher frequency of neurological adverse events and mortality as compared to other commercially available left ventricular assist devices (LVAD).

The communication from Medtronic set out that prophylactic explant (precautionary removal) of the HVAD™ System is not recommended because the pump may experience a delay to restart or a failure to restart. Medtronic advise that the risks associated with explantation may outweigh the potential benefits and that any decision regarding explant and exchange of the HVAD™ pump should be made by physicians on a case-by-case basis and where pump exchange is appropriate, the HVAD should be replaced by an alternative LVAD.

A number of field safety notices (FSN) have been issued about the device.

Leigh Day product safety solicitor Zahra Nanji commented:

“A device which keeps the heart pumping is of course a device which needs to have the highest levels of safety and efficiency. The number of FSN and alerts relating to the HVAD indicate that the device has posed a known risk of failure for some time. By their own account, Medtronic acknowledge that risk of failure in the HVAD is higher than other comparable devices on the market. Knowing this, it should not take 14 HVAD failures and 14 deaths for a device to be recalled.

“The decision to recall should not just be left to a manufacturer and their surveillance systems to recognise a problem with a device. There needs to be a more rigorous proactive monitoring and recall system for medicines and devices, something which is currently lacking in the UK.

"This was highlighted in the report from the Independent Medicine and Medical Devices Safety Review entitled, First do No Harm, led by Baroness Cumberledge, published in July 2020 where Baroness Cumberlege, amongst the nine recommendations made in that report, recommended substantial revision of the MHRA, particularly in relation to adverse event reporting and medical device regulation. This call for reform of the system has been one which has been made by reviews and commentators for many years. It is clear that revision of the medicines and healthcare products and devices system needs to be implemented now.”