FDA Issues Safety Communication on Implantable Left Ventricular Assist Devices

August 5, 2015—The US Food and Drug Administration (FDA) is alerting health care providers, patients, and caregivers about serious adverse events associated with left ventricular assist devices (LVADs). These adverse events include an increased rate of pump thrombosis with the HeartMate II LVAD device (Thoratec Corporation) and a high rate of stroke with the HeartWare HVAD system (HeartWare, Inc.) since approval of the devices. The FDA is also aware of bleeding complications related to both the HeartMate II and HeartWare HVAD, advised the agency.

The communication stated that the FDA believes the benefits of these LVADs continue to outweigh the risks when used for the currently approved indications (bridge-to-transplant or destination therapy) in appropriately selected patients. However, the FDA also believes it is important for health care providers and patients to be aware of this important information when considering the use of these devices and clinical management of their patients.

The FDA recommended that health care providers perform a thorough clinical evaluation, assessing the benefit-risk profile of each patient in determining the most appropriate treatment plan and, if necessary, selecting a device; consider the risks for pump thrombosis, stroke, and bleeding when determining the appropriate therapy for individual patients; and review the current device labeling before making treatment decisions if considering the use of either of these devices. 

All explanted LVAD devices and components should be returned to their respective manufacturer. In the case of LVAD-related pump thrombosis and other adverse events, manufacturer evaluation of the affected device is critical to better understand the reasons for these adverse events, stated the FDA.

Adverse events or side effects related to the use of these products can be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program, which is available online at www.fda.gov/MedWatch/report. The full FDA safety communication is available online here.