Company-led oversight
If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.
By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.
Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.
Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.
Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.
Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.
In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.
But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.
In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.
In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.
The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.
In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”
The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.
Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.
“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”
Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”
HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.
A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.
Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.
A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.