A heart pump with a history of manufacturing and quality issues was implanted into thousands of patients even after the FDA was aware the device did not meet federal standards, according to an investigative report ProPublica published Aug. 5.
Five takeaways:
1. The FDA first identified manufacturing issues involving the HeartWare Ventricular Assist Device in 2011, a year before the device hit the market. The agency found more safety lapses in 2014 and issued a warning letter to the heart pump's maker, HeartWare, which Medtronic acquired in 2016. According to ProPublica, the FDA relied on HeartWare and Medtronic to voluntarily address the issues instead of forcing them to do so by issuing an injunction or fines. The companies were never penalized by the FDA when they failed to correct issues by set deadlines, according to the report.
2. From 2014 to present, the companies issued 15 serious recalls about the heart pump. The FDA shared formal notices and repeatedly alerted healthcare providers of the issues, but many patients were unaware, the report found. More than 19,000 patients were implanted with the device, which is meant to keep heart failure patients alive while they wait for a transplant. Most of these patients received the device after 2014, when the FDA knew it did not meet federal standards, according to ProPublica. By 2020, the FDA had received more than 3,000 reports of patient deaths potentially linked to the device.
"Medtronic continuously evaluates our devices at each stage of their life cycles to ensure we are meeting regulatory requirements and the evolving needs of patients and the healthcare professionals that serve them," the company said in a statement to Becker's. "We regularly receive and evaluate real-world information to identify, address, correct and communicate issues when they arise."
3. Medtronic pulled the device from the market in June after finding a competing device from Abbott produced better clinical outcomes. The American College of Cardiology called Medtronic's move "a success of medical device feedback and monitoring" in an Aug. 5 article. The field of left ventricular assist devices is constantly evolving, the group said, adding that Abbott's device was built upon lessons learned from competitors and preceding devices.
4. Before stopping sales of the heart pump, Medtronic said it worked closely with Abbott to ensure alternative device options were available for patients. The company also has a program to support, monitor and inform about 4,000 patients implanted with the device and their caregivers.
"The decision to withdraw HVAD is consistent with our deeply held commitment to design and manufacture medical technology that improves patient health outcomes," Medtronic told Becker's. "Medtronic respects the physician-patient relationship and is focused on working with healthcare providers to ensure that there is no gap in patient care. … Clinical and technical teams are and will continue to be available to ensure ongoing patient support."
5. The FDA said it has actively monitored issues with the heart pump and met with Medtronic more than 100 times after it acquired HeartWare to review safety concerns and ensure they were being corrected. The FDA also launched formal reviews of new device modifications and tracked whether the heart pump had a "reasonable assurance of safety and effectiveness," the agency told ProPublica.
"The patients and providers who rely upon this life-sustaining device to treat advanced, end-stage heart failure were always at the forefront of our decision-making," an FDA spokesperson said in a statement to Becker's. "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."