Important Warning from FDA for LVAD Implant Patients

Many Americans suffer from heart problems. While many of these cardiovascular issues can be managed through diet, exercise, and medications, some require more extreme measures. In the case of heart failure, an implant called a left ventricular assist device (LVAD) may be used. An LVAD is a battery-operated implant that helps the heart pump when it can’t do it on its own. The pump is inside the body, while a power pack and controller are used outside of the body

This device assists patients who are waiting for a heart transplant, since acquiring one can take many years, and during that time, the heart can weaken tremendously – to the point where the patient could even die. In fact, AN LVAD often works so well that it can be used for the rest of patient’s life when a heart transplant no longer becomes viable.

While these devices may seem like lifesavers for those with weak hearts, they are not without side effects. In the fact, the Food and Drug Administration is now warning patients, caregivers and health care providers about adverse events that have recently come to the agency’s attention. There are two types of LVADs that the FDA has approved.

Specifically, the HeartMate II Left Ventricular Assist System, manufactured by Thoratec Corporation, has been associated with blood clots inside the pump. This is also known as pump thrombosis. The other LVAD, the HeartWare Ventricular Assist System HVAD, which is manufactured by HeartWare, Inc., has been associated with an increased risk of stroke. Both devices have also been known to cause bleeding complications.

In the HeartMate II device, patients are experiencing pump thrombosis earlier and at a higher rate than observed in clinical trials. In the clinical trial, only 1.6% of patients experienced this at one year, while the reality is that more than 8% of patients are experiencing pump thrombosis at just three months after implantation. If a patient is diagnosed with this event, the pump may need to be removed and replaced, requiring an additional surgery. In some cases, it can even lead to death.

The HeartWare HVAD has shown a very high rate of stroke – more than double the rate of the other LVAD, the Heartmate II. Nearly 29 percent of patients had experienced a stroke within two years of implantation, compared to just 12% for the Heartmate II. Stroke is a serious medical condition that can lead to disability or even death.

It is unknown what is causing the bleeding in some patients. In order to reduce the risks of stroke and pump thrombosis, anticoagulation therapy is used. This causes blood thinning and could be leading to the bleeding. However, there could be other factors involved as well. In any case, bleeding is a serious issue that could lead to death.

The FDA understands these are serious risks, but has allowed health care providers and patients to continue using these LVAD devices

LVADs are life-saving devices and their benefits outweigh the risks when used appropriately. The FDA simply recommends that health care providers use caution when selecting a device. Doctors should carefully evaluate each patient’s medical history and lifestyle and determine which device, if any, will work best. Patients should also take control of their health and make sure health care providers are aware of any concerns or medical history that could increase their chances of experiencing adverse events.

The FDA is working with both manufacturers to include these adverse events on the labeling. The agency expects that any patient or health care provider suffers any serious medical conditions due to the LVAD device will contact them.

If you believe that you or a loved one have been injured due to an LVAD implant, contact the defective medical device attorneys at Nadrich & Cohen, LLP. We have recovered millions of dollars on behalf of victims and their families. Contact us today.