Patients implanted with HeartWare International’s Ventricular Assist System (VAS) have submitted dozens of adverse event reports to the U.S. Food and Drug Administration, including one patient who suffered a fatality from the device.
What Is a Ventricular Assist System?
People whose hearts are failing but are waiting for a transplant need mechanical assistance pumping blood from the left ventricles of their hearts to the rest of their bodies. HeartWare’s VAS consists of a pump (called an “HVAD”) inserted into the bottom of the left ventricle with a tube connecting it to the aorta, the body’s primary blood vessel for moving oxygenated blood into the rest of the body. The HVAD is also connected to a cable that exits the patient’s body and links to a controller and battery pack. The HVAD can pump up to 10 liters of blood per minute.
The Ventricular Assist System Might Cause Serious Side Effects
HeartWare International is an Australia-based company, and the FDA approved the VAS in November 2012. Nevertheless, more than 60 recipients have filed adverse event reports with the agency due to perceived malfunctions in the devices that sometimes produce fatal results.
For example, one recipient suffered a “controller fault alarm” after changing the batteries in the device. The VAS stopped pumping blood throughout the recipient’s body, causing her death.
Another VAS recipient’s autopsy revealed that the pump contained a blood clot.
Other recipients who survived their malfunctions found that a blood clot had formed in the device’s pump.
RLG’s Ventricular Assist System Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Ventricular Assist System lawsuit on your behalf if necessary. RLG will also keep you up to date on any Ventricular Assist System class action lawsuits, FDA Ventricular Assist System warnings, and Ventricular Assist System FDA recall announcements. If you or a loved one received a Ventricular Assist System and believe it caused an injury, contact RLG today.