Abbott Warns of New Problems With HeartMate 3 Systems

The HeartMate 3 Left Ventricular Assist Device (LVAD) may unexpectedly stop working, according to a warning issued by the manufacturer, which indicates that patients may experience serious and potentially fatal injuries if problems occur due to an improper connection or the presence of static electricity.

Abbott Laboratories sent out a HeartMate 3 Medical Device Advisory (PDF) on December 2, indicating that the devices could lose power when changing the controller on the pump, if the modular cable is connected at an incorrect angle.

The HeartMate 3 System helps deliver blood from the heart to the rest of the body. It is used to support patients who are at risk of death from end-stage left ventricular heart failure. Patients typically use the device for short-term periods, such as when they are awaiting a heart transplant.

The LVAD includes a blood pump implanted into the pericardium; the space around the heart. It also includes an outflow graft that connects the pump to the aorta.

HeartMate 3 systems require the controller exchanges on the pumps be replaced periodically by medical professionals. However, patients are often trained to perform these changes in the case of emergency.

Abbott warns that when the modular cable is incorrectly connected at an 180 degree angle from the proper orientation, there is potential for erroneous electrical contact to be made, which may cause a blown fuse, confusion for the patient, and the controller to alarm with “Controller Fault.”

The manufacturer has received at least two serious injury reports involving the presence of static electricity causing power loss to patients’ HeartMate mobile power unit modules, according to the statement. To date, the rate of reported deaths associated with this event is 0.5% and the rate of reported hemodynamic compromise is 0.07% associated with this issue.

Abbott recommends patients using the affected devices always have a caregiver present and follow all labeling instructions when exchanging the controller outside of the hospital setting. Patients should make sure they pay specific attention to the markings on the controller and driveline when inserting the backup controller.

The HeartMate series of implants have been linked to a number of problems in recent years.

In May 2018, the U.S. Food and Drug Administration (FDA) announced a Class I HeartMate 3 recall, impacting more than 5,000 devices, due to the potential for the outflow graft assembly to experience a malfunction causing the graft to twist and occlude, or close up, over time. Officials warned occlusion of the outflow graft may reduce or stop the pump flow which could lead to serious side effects, such as bloods clots, or even death.

In 2017, Abbott recalled 29,000 HeartMate II LVAS Pocket System Controllers following 26 reports of patient deaths due to the devices malfunctioning after patients tried to change the controller improperly or too slowly. The devices were not withdrawn from the market, rather, Abbott provided patients with a fully upgraded system with new yellow alignment markings and new drivelines.