HeartWare VAD Problems May Have Caused Serious Injuries, Deaths: FDA
According to an FDA warning letter sent to HeartWare Inc., problems with the HeartWare Ventricular Assist Device (HVAD) may have caused at least two deaths and four serious injuries, with the federal regulatory agency indicating that the manufactured dropped the ball on fixing the issues.
FDA investigators found a number of deficiencies at the HeartWare Miami Lakes, Florida, facility, particularly involving the manufacturer’s process for making sure that some corrections made to the HVAD actually work.
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The HeartWare VAD, also known as the HVAD, is used as a bridge device on patients suffering from advanced heart failure while they await cardiac transplantation. It is used during emergency medical flights on airplanes and helicopters, as well as in hospitals, to keep patients alive until a heart transplant can be performed.
In December, a HeartWare VAD recall was issued because the driveline connector locking mechanism on the device may fail to engage in some units. As a result, the device could fail and stop pumping, leading to serious injury and death.
Over the last three years, HeartWare has also received at least 27 complaints about the controller for the HVAD, according to information contained in the FDA warning letter. The controller provides power to the HeartWare VAD and helps monitor it, but can fail due to electrostatic discharge (ESD). These failures may have resulted in the deaths of two patients and left four others seriously injured.
In the warning letter, the FDA said that the company’s response to the HeartWare VAD problems have been inadequate, and do not meet current good manufacturing practice (cGMP) requirements for medical devices.
The letter accuses the company of failing to establish and maintain procedures for validating the device’s design, particularly the design of the controller; failing to implement corrective and preventative actions after receiving numerous complaints; failing to maintain records of the investigation into problems with the HVAD; and failing to validate computer software used as part of its quality control system.
The FDA says that the company responded to complaints and problems, but did not have the proper procedures in place to make sure those responses actually worked.
“Your firm received at least 27 complaints between February 2010 and November 2013, including reports of 2 deaths and 4 serious injuries, or HVAD controller failure for which ESD was determined to be the most likely root cause,” the letter states. “Your firm initiated corrective actions including labeling changes to the Patient Manual released to new patients in July 2013 and a Safety Alert Letter to doctors in May 2013. However, your firm failed to verify or validate the effectiveness of these corrective actions.”
The FDA letter demanded that the company explain how it intended to address the problems and prevent them from occurring in the future.
“HeartWare takes this matter seriously and will respond to the letter within the required 15 days,” the company stated in the press release. “The company expects to implement new and enhanced systems and procedures, and will perform additional actions as may be required to resolve the issues raised in the FDA communication.”
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