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Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication - Serious Adverse Events
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 --
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:
Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:
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