- HeartMate II Left Ventricular Assist System manufactured by Thoratec Corporation
- HeartWare Ventricular Assist System HVAD manufactured by HeartWare, Inc.
AUDIENCE: Cardiology, Surgery, Risk Manager
ISSUE: FDA is alerting health care providers, patients, and caregivers about serious adverse events associated with LVADs. These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices. FDA is also aware of bleeding complications related to both the Thoratec HeartMate II and HeartWare HVAD. See the FDA Safety Communication for more detailed information.
When used for the currently approved indications in appropriately selected patients, FDA believes the benefits of these LVADs continue to outweigh the risks. 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.
BACKGROUND: LVADs are approved for bridge-to-transplant (BTT) or destination therapy (DT). BTT refers to providing circulatory support to a patient at risk of imminent death from non-reversible left ventricular heart failure until a donor heart becomes available for a heart transplant. DT refers to providing circulatory support to a patient with end-stage left ventricular heart failure who is not candidate for a heart transplant.
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.
- Review the current device labeling prior to making treatment decisions if you are considering using either of these devices.
- Return all explanted LVAD devices and components 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.
- Discuss openly and in detail the benefits and risks of any therapy being considered by your heart failure specialist, cardiologist and surgical team. This discussion should include:
a) your risks of developing an adverse event like a blood clot or stroke and the potential side effects if you do experience an adverse event.
b) how the benefits and risks of the device compare to other non-LVAD medical therapies.
- If you have any concerns regarding your device, discuss them with the health care providers managing your heart failure.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/05/2015 - Safety Communication - FDA]