After issuing a series of Class I recalls for HeartWare HVAD systems over the past decade, Medtronic has announced that it will remove the cardiac devices from the market, as new data highlights a growing number of adverse neurological events and increased mortality rates among patients.
The Medtronic HeartWare HVAD market removal was announced by the U.S. Food and Drug Administration (FDA) on June 3, instructing healthcare providers to no longer implant end-stage heart failure patients with the HeartWare Ventricular Assist Device (HVAD) System, due to a risk of pump failures.
The HeartWare Ventricular Assist Device (HVAD) by Medtronic first received premarket approval from the FDA in November 2012, with a design intended to help pump blood from the heart to the rest of the body among patients who are awaiting a heart-transplant and at risk of death from end-stage left ventricular heart failure.
The system includes a pump implanted in the space around the heart, with a controller that regulates the speed and function of the pump. Benefits of the devices included the ability to be used in either a hospital setting or during patient transport. However, over the last decade, Medtronic has issued at least 13 recalls involving component defects and malfunctions, ranging from startup failure to the company needing to update instructions for use and patient manuals.
In April, the FDA announced a Medtronic Heartware HVAD recall, indicating the controller and power cabling may be prone to unexpected failure and cause the devices to stop functioning.
In May 2020, Medtronic issued another HeartWare HVAD Class I recall following nearly 100 reports of problems where the strain relief screw broke and outflow graft tore while preparing the device for implant, putting patients at risk of suffering serious injuries, including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, and the need for additional medical procedures or death.
In the recent Medtronic HVAD Urgent Medical Device Communication issued this week, which instructs healthcare professionals to stop implanting the devices immediately, the manufacturer indicates there have been over 100 complaints involving a delay or failure to restart the HVAD internal pump, which has caused a total of 14 deaths and 13 pump removal surgeries.
Medtronic announced in its communication “a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System as compared to other circulatory support devices available to patients.”
Although recent investigations by Medtronic have identified the root cause of the failure and restart issues in several lots of the devices, no root cause has been pinpointed in thousands of other devices to prevent HVAD pump restart failures.
Medtronic indicates that due to the inability to identify the defect, the pumps may potentially worsen a patient’s heart condition, leading to a heart attack, stroke or require hospitalization resulting in death.
The FDA announced this week Medtronic will be ceasing all distribution and sale of the HeartWare HVAD devices and is instructing healthcare professionals to no longer implant end-stage heart failure patients with Medtronic’s HeartWare, and instead use an alternative device, such as the Abbott HeartMate.
Currently, Medtronic states there are approximately 2,000 patients in the U.S. implanted with the HeartWare HVAD devices and 4,000 worldwide.
Medtronic is advising patients who have the HVAD System to continue normal use of device components and to contact the company for replacement items, such as controllers, batteries, AC/DC adapters and carrying case. The manufacturer will also be notifying healthcare providers and patients that elective explants are not recommended and that decisions to remove the HVAD pumps should be made on a case-by-case basis, with careful consideration to the patient’s surgical risks.