FDA Warns Of Serious Adverse Events, Including Clots, Strokes, With 2 LVADs
(September 2, 2015, 10:07 AM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on Aug. 5 warned health care providers about serious adverse events associated with left ventricular assist devices (LVADs), including the HeartMate II Left Ventricular Assist System made by Thoratec Corp. and the HeartWare Ventricular Assist System HVAD made by HeartWare Inc.
The FDA said serious adverse events include an increased rate of pump thrombosis (clots within the pump) with the Thoratec HeartMate II and a high rate of stroke in patients using the HeartWare HVAD. The agency...