REPRESENTING VICTIMS OF DANGEROUS VENTRICULAR ASSIST DEVICES
The HeartWare Ventricular Assist System, a left ventricular assist device (LVAD), was approved by the Food and Drug Administration (FDA) in 2012. LVADs help heart function and blood flow in patients waiting for heart transplantation who may be at risk of death from left ventricular heart failure. The devices can also be used in emergency situations, including during patient transport.
The system includes two parts: a pump, which is implanted in the space around the heart, and a controller, which controls the pump’s speed and function.
Unfortunately, this potentially dangerous medical device has been linked to more than 500 adverse events and scores of deaths, according to the Manufacturer and User Facility Device Experience (MAUDE). Issues with the device’s external controller, batteries, and driveline connector are believed to be the causes of many of these issues.
HISTORY OF HEARTWARE RECALLS AND FDA WARNINGS
In the clinical trials leading to the device’s approval, the rate of adverse events was comparable to that of the control treatment (a different type of LVAD). However, the device was linked increasing the risk of stroke. Despite this potential hazard to patients with the device, the FDA determined the benefits of the device outweighed the risks.
In December 2013, HeartWare issued a recall due to an issue with the driveline connector of the VAD, which could cause the pump to fail. A few months later, HeartWare issued a warning after discovering that the batteries inside the device could deplete at an earlier time than was expected.
In June 2014, HeartWare received its first warning letter from the FDA. In the letter, the agency warned that problems were discovered at the company’s manufacturing facility in Florida. The FDA told the company to resolve several issues, including procedures pertaining to device design and labeling and procedures for implementing corrective actions.
Less than a year after the company’s first VAD recall, HeartWare issued a Class I recall due to safety problems regarding the battery life in their devices. The company admitted that there were three deaths caused by either a power source disconnect or an old battery.
ADVERSE EVENTS LINKED TO HEARTWARE VAD
In 2015, the FDA sent out a safety communications letter to health care providers, patients, and caregivers regarding implantable LVADs. The agency addressed severe adverse events that have been linked to the only two LVADs available on the market: HeartWare’s Ventricular Assist System and The HeartMate II Left Ventricular Assist System.
According to the FDA, results from a clinical trial showed that the HeartWare VAD increased the risk of stroke when used in patients with end-stage left ventricular heart failure who is not a candidate for a heart transplant, compared to the HeartMate II device. HeartWare’s VAD is not currently approved for this usage. In addition, the FDA warned of the increased bleeding risk associated with both VADs.
In the warning letter, the FDA maintains that the device’s benefits outweigh the risks, but healthcare providers should assess the benefit-risk profile for each individual patient.
CONTACT AN EXPERIENCED DANGEROUS MEDICAL DEVICE ATTORNEY
If you or a loved one have been the victim of a faulty HeartWare left ventricular heart device, you may be entitled to compensation. LVADs have been linked to an increased risk of stroke and bleeding complications that can lead to serious injuries and even death. Our experienced defective medical device lawyers are available 24/7, nights and weekends to take your call and evaluate your claim. Thomas J. Henry has the financial and legal resources you need to properly pursue a case against large pharmaceutical companies. Contact us today for a free legal consultation.