The Food and Drug Administration (FDA) is notifying health care providers not to implant Medtronic’s Heartware™ Ventricular Assist Device (HVAD) System in end-stage heart failure patients due to an increased risk of neurological adverse events and mortality, as well as complaints that the internal pump may delay restarting or fail to restart.
The HeartWare HVAD System is currently approved as a bridge to heart transplantation in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery and as destination therapy in patients for whom a heart transplant is not planned.
Compared with other commercially available durable left ventricular assist devices, the Medtronic HVAD System has demonstrated a higher frequency of neurological adverse events and mortality, according to a growing body of observational clinical comparisons. Medtronic has also received over 100 complaints involving a delay or failure to restart of the HVAD pump. These reports included 14 deaths and 13 cases where an explant was required.
Consequently, Medtronic has decided to stop the distribution and sale of the HVAD System and has issued an Urgent Medical Device Communication Notification Letter to health care providers to immediately stop new implants of the device. The letter informs health care providers to use alternative devices such as the Abbott HeartMate™ 3 Left Ventricular Assist System. Patients currently implanted with the device should be advised to continue with existing procedures and protocols for the device and to contact the Company for necessary replacement of peripheral components (eg, controllers, batteries, AC/DC adapters, carrying case).
According to the Company, elective removal of the Medtronic HVAD System is not recommended at this time as the risks associated with an explant outweigh the potential benefits. Removal and/or exchange of the device should be made on a case-by-case basis, considering the patient’s clinical status and surgical risks.
Adverse events or safety issues with the HVAD System should be reported to the FDA’s MedWatch Adverse Event Reporting program.
- FDA alerts health care providers to stop new implants of certain ventricular assist device system. [press release]. Silver Spring, MD: US Food and Drug Administration; June 3, 2021.
- Stop new implants of the Medtronic HVAD System – letter to health care providers. [press release]. Silver Spring, MD: US Food and Drug Administration; June 3, 2021.