FDA: Serious adverse events associated with LVADs

Editor's Note

The Food and Drug Administration on August 5 issued a Safety Communication on serious adverse events linked to left ventricular assist devices (LVADs).

Two implantable LVADs are approved by the FDA (HeartMate II by Thoratec Corporation and HeartWare HVAD by HeartWare Inc), and serious events have been associated with both.

Adverse events include an increased rate of pump thrombosis with HeartMate II and a high rate of stroke with HeartWare HVAD. Bleeding complications have also been associated with both devices.

Date Issued: August 5, 2015 Audiences: Health care providers treating heart failure patients Patients with a LVAD Caregivers of patients with a LVAD Specialties: Cardiology, Cardiac Surgery, Heart Failure, Heart Transplantation Product: Implantable LVADs help the left ventricle (the main pumping chamber of the heart) circulate blood throughout the body in patients with advanced heart failure.