FDA, Medtronic alert doctors to halt implantation of ventricular assist device system
Click Here to Manage Email Alerts
The FDA and Medtronic alerted health care providers to no longer implant patients with end-stage HF with a ventricular assist device system.
According to an FDA press prelease, Medtronic halted the sale and distribution of its ventricular assist device system (Heartware HVAD System) due to the frequency of neurological adverse events and mortality compared with other commercially available devices. Prior to the total recall, Medtronic had issued a separate recall based on complaints that the internal pump may delay or fail to restart.
Medtronic has issued an urgent medical device communication notification letter requesting physicians stop new implants of the device.
According to the release, the company received more than 100 complaints involving delay or failure of the pump to restart, which included 14 reports of patient deaths and 13 cases where an explant was necessary.
According to Medtronic, approximately 2,000 patients in the U.S. were implanted with the device and 4,000 were implanted worldwide.
The FDA is advised health care providers to follow the instructions in Medtronic’s notification letter and to stop new implants of the ventricular assist device system and use an alternative. The agency advised patients who received the system to continue normal use of device components.
“The FDA’s highest priority is patient health and safety. We have been carefully monitoring the adverse events associated with this device and support its removal from the marketplace. The FDA is working closely with both Medtronic and Abbott to ensure patient care is optimized during this transition period and that there is an adequate supply of devices available to provide this patient population with options for end-stage heart failure treatment,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the release. “The FDA’s alert is designed to quickly inform health care providers of this critical information so that patients with the current HVAD System continue to receive appropriate care and management. The FDA is committed to facilitating the development of safe and effective devices that can provide patients living with the devastating condition of end-stage heart failure with the opportunity for improved quality of life.”
Perspective
Back to Top
This is a surprising alert from Medtronic and the FDA to stop all implants of the Medtronic HVAD system. The Medtronic communication was sent worldwide and suggested all new implants be immediately stopped and an alternative device used.
For some time there had been a suggestion of a higher stroke risk with the HVAD system. It seems in light of a recall of certain pumps in December 2020 for failure to start/restart, an independent quality panel was commissioned to review the device and patient management issues. The number of cases reviewed showed serious adverse events related to the pump malfunction and neurologic event rate.
I have never had patients implanted with the Medtronic HVAD, but I have discussed the increased neurologic event rate with colleagues and even seen trends in the published literature. As I am not at a center that implants HVAD, I was not familiar with the pump restart issue until this report.
The only other comparable durable LVAD is the Abbott HeartMate 3. Because the number of HVAD implants is not excessively high, I do not foresee a durable VAD shortage resulting in prolonged wait times or adverse outcomes from waiting too long to implant a VAD.
At the present time, it is recommended that patients currently on support with the HVAD system continue with the Medtronic system. I presume the implanted patients will continue to be closely followed, but in light of these major issues with the device, it is unclear how many more adverse outcomes with HVAD would be needed to shift the risk benefit ratio in favor changing the HVAD system to HeartMate 3.
Collapse
Click Here to Manage Email Alerts