Warning signs
In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.
A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.
The HVAD offered a smaller option that could even be used in children, and it led to a string of publicized successes. A fitness model was able to return to the gym. A 13-year-old with heart defects could attend school again. Medtronic’s YouTube page features 16 interviews with grateful patients and families.
The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.
The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.
For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.
But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.
Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.
Then, in 2014, the FDA found more serious lapses, detailed in federal inspection reports.
For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.
The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.
Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.
Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”
The 15-day deadline passed, and the FDA never penalized the company.
The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.
But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.
Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.
Again, the inspection report said the company “promised to correct” the issues.
“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”
By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.
One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.