A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced this week, years after surgeons had first pointed out problems with the pumps.
The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4 500 reports in which the medical device may have caused or contributed to a patient’s death.
The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec, a subsidiary of Abbott Laboratories.
The devices are not currently being removed from the market, but Abbott said it had communicated the risk to customers this year, reports Medpage Today.
The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported. The heart devices in question have been associated with thousands of reports of patients' injuries and deaths, as described in a KFF Health News investigation late last year.
“Why doesn’t the public know?” asked Sanket Dhruva, MD, a cardiologist and an expert in medical device safety and regulation at the University of California San Francisco.
Though some surgeons may have been aware of issues, others, particularly those who do not implant the device frequently, may have been in the dark.
The recall involves a pair of mechanical pumps that help the heart pump blood when it can’t do so on its own. The devices, small enough to fit in the palm of a hand, are implanted in patients with end-stage heart failure who are awaiting a transplant or as a permanent solution when a transplant is not an option.
The recall affects nearly 14 000 devices.
Amanda Hils, an FDA press officer, said the agency was working with Abbott to investigate the reported injuries and deaths and determine if further action was needed.
“To date, the number of deaths reported appears consistent with the adverse events observed in the initial clinical trial," Hils said.
The FDA’s recall notice warned the devices could cause build-up of “biological material” that reduces their ability to help the heart circulate blood and keep patients alive. The build-up accumulates gradually and can appear two years or more after a device is implanted.
Doctors were advised to watch out for “low-flow alarms” on the devices and, if they do diagnose the obstruction, to either monitor the patient or perform surgery to implant a stent, release the blockage, or replace the pump.
“Rates of outflow obstruction are low,” Abbott spokesperson Justin Paquette said, adding that patients whose devices are functioning normally “have no reason for concern”.
Second in months
This week’s alert is the second class 1 recall of a HeartMate device this year. In January, Abbott issued an urgent “correction letter” to hospitals about a separate issue in which the HeartMate 3 unintentionally starts and stops due to the pump’s communication system, which cardiologists use to assess patients’ status.
The FDA alerted the public in March.
In February, Abbott had issued another urgent letter to hospitals about the blockage problem, asking them to inform physicians, complete and return an acknowledgment form, and pay attention to low-flow alarms on the device’s monitor that may indicate an obstruction.
The company said it was working on “a design solution” to prevent the blockages.
The only other class 1 recall issued for the HeartMate 3 was in May 2018, when the company issued corrective action notices to hospitals and physicians warning that the graft line that carries blood from the pump to the aorta could twist and stop blood flow.
The FDA recall notice issued this week includes additional guidance for physicians to diagnose the blockage using an algorithm to detect obstructions and, if needed, a CT angiogram to verify the cause.
At present, the HeartMate 3, which was first approved by the FDA in 2017, is the only medical option for many patients with end-stage heart failure and who do not qualify for a transplant. The HeartMate 3 has supplanted the HeartMate II, which received FDA approval in 2008.
If the new recall leads to the device being removed from the market, end-stage heart failure patients could have no options, said Francis Pagani, MD, a cardiothoracic surgeon at the University of Michigan who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.
If that happens, “we are in trouble”, Pagani said. “It would be devastating to the patients to not have this option. It’s not perfect – no pump ever is – but this is as good as it’s ever been.”
It’s not known precisely how many patients have received a HeartMate II or HeartMate 3 implant. That information is proprietary. The FDA recall notices show worldwide distribution of more than 22 000 HeartMate 3 devices and more than 2 200 of the HeartMate II.
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