FDA issued warning letters, and yet HVAD continued to be used.
The Food and Drug Administration (FDA) sent a warning letter to HeartWare concerning its HeartWare Ventricular Assist Device, or HVAD, after discovering the company had not been monitoring or repairing the heart pump’s defects. More warnings followed, pointing out faulty batteries and short circuits caused by static electricity, which had killed patients who underwent surgery implanting the device. The agency demanded that the company repair these defects within fifteen days of each letter’s date, and yet, safety concerns went unaddressed.
John Winkler II was dying of heart failure when offered HVAD as an option until a heart transplant was available. Winkler was only 46, and in August 2014, he had surgery to implant the device. A cable was attached to a small incision in his waist and connected to a battery-powered controller strapped to his body. An alarm would sound if something went wrong.
Winkler returned home, and his wife, Tina Winkler said, “He was doing so much better. We thought he was coasting until he got his transplant.” However, in December 2014, Winkler’s teenaged children heard the HVAD’s alarm and called 911. They found their father collapsed on his bedroom floor, and he died two days later.
The family filed a wrongful death lawsuit against Medtronic, the company that acquired HeartWare in 2016, and settled with the company, which did not admit to any wrongdoing. The FDA had failed to follow up with the warnings it sent even after HeartWare and Medtronic failed multiple inspections. The agency simply relied on the device makers to voluntarily fix the problems as the number of fatalities steadily increased. HVAD was implanted into more than 19,000 patients, and by the end of last year, the agency had received more than 3,000 reports of patient deaths. The FDA never issued penalties to HeartWare or Medtronic even as the device maker issued fifteen HVAD recalls beginning in 2014.
“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco. “How can you not take action on a warning letter with these serious issues with very sick patients?”
The federal agency claims that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure compliance. The agency also said it “initiated formal reviews of new device modifications and continually tracked whether the HVAD had a reasonable assurance of safety and effectiveness.” Dr. William Maisel, the director of product evaluation and quality at the FDA’s device division, said, adding, “Our decisions that we made along the way have always been patient-focused. More than 80% of companies fix their problems by the time the FDA reinspects.”
However, that’s not what happened with HVAD, and in the two-year period between 2016 and 2018, even as meetings with the company were underway, the defects were not fixed. It wasn’t until June of this year that Medtronic stopped HVAD sales and implants, demonstrating that the system does not always work (to the detriment of those who trust it will).