Medtronic did not take HVAD off the market, even after the deaths –
The FDA issued warning letters, yet HVAD continued to be used.
The Food and Drug Administration (FDA) sent HeartWare a warning letter regarding its HeartWare ventricular assist device, or HVAD, after discovering that the company had failed to monitor or repair heart pump defects. Further warnings followed, highlighting faulty batteries and short circuits caused by static electricity, which had killed patients who had had surgery implanting the device. The agency demanded that the company repair these defects within fifteen days of the date of each letter, and yet the security concerns have not been resolved.
John Winkler II was dying of heart failure when offered the optional HVAD until a heart transplant was available. Winkler was only 46 years old, and in August 2014, he underwent surgery to implant the device. A cable was attached to a small incision in his waist and connected to a battery-powered controller attached 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 teenage children heard the HVAD alarm and called 911. They found their father collapsed on the floor of his bedroom 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 any wrongdoing. The FDA had failed to act on the warnings it sent, even after HeartWare and Medtronic failed multiple inspections. The agency simply relied on device makers to voluntarily fix the issues as the number of deaths steadily increased. HVAD has been implanted in 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 has never imposed sanctions on HeartWare or Medtronic, although the device’s maker has issued fifteen HVAD recalls as of 2014.
“Patients have no idea and they rely on the FDA to ensure the safety and efficacy of high-risk devices,” said Dr. Rita Redberg, cardiologist at the University of California, San Francisco. “How can you not follow up on a warning letter about these serious issues with very sick patients?” “
The federal agency says that after the acquisition of HeartWare by Medtronic in 2016, it met with the company more than 100 times to ensure compliance. The agency also said it “had initiated formal reviews of new modifications to the device and continuously checked whether the HVAD had reasonable assurance of safety and effectiveness.” Dr William Maisel, Director of Product Evaluation and Quality in the Devices Division of the FDA, said, adding, “Our decisions we made along the way have always been patient-centered. Over 80% of companies resolve their issues by the time the FDA re-inspects.
However, that is not what happened with HVAD, and during the two year period between 2016 and 2018, even as meetings with the company were underway, the flaws were not corrected. It wasn’t until June of this year that Medtronic stopped sales and HVAD implants, demonstrating that the system doesn’t always work (to the detriment of those who trust it).
Thousands of patients have been implanted with heart pumps that the FDA knew could be dangerous
FDA alerts healthcare providers to stop new implants in certain ventricular assist device systems