Thousands of Patients Received Heart Pump with Known Safety Issues, ProPublica Finds
By Mackenzie Bean
Thousands of patients received the HeartWare Ventricular Assist Device even after the Food and Drug Administration (FDA) was aware the medical device did not meet federal standards, ProPublica reports. A new investigative report found that more than 19,000 people were implanted with the device — which is used to keep heart failure patients alive while they await a transplant — with most of the implants occurring after 2014. HeartWare and Medtronic, which acquired HeartWare in 2016, issued 15 serious recalls about the heart pump starting in 2014. However, FDA first noted manufacturing problems with the heart device as early as 2011, a year before the product became available, and then found more serious issues in 2014, issuing a warning letter to the manufacturer. According to the ProPublica report, the agency relied on the companies to voluntarily address the lapses and were never penalized for failing to resolve issues by established deadlines. In June, Medtronic pulled its device from the market after determining a heart pump from Abbott generated improved clinical outcomes. Medtronic noted it worked closely with Abbott to make sure there were alternative options available to patients, and the company has a program in place to support and monitor some 4,000 patients who received its device and their caregivers. For its part, FDA said it has been closely monitoring the product and met with Medtronic more than 100 times following its acquisition of HeartWare to review safety concerns and make sure they were being addressed. In addition, the agency launched formal reviews of new device modifications and monitored whether the device had a "reasonable assurance of safety and effectiveness." An FDA spokesperson noted, "The FDA is continuing to work with Medtronic to ensure that all deficiencies are resolved, and with Abbott, to ensure an adequate supply of HeartMate 3 devices are available for future patients."
Read the full article on Becker's Hospital Review.