Manufacturer pulls products following reports of neurological events, death

The FDA issued an alert to health care professionals warning them to stop implanting patients with end-stage heart failure with Medtronic’s Heartware Ventricular Assist Device (HVAD) system due to reports of device malfunctions and a heightened risk for neurological adverse events and death compared to other devices.

According to the more than 100 complaints received by Medtronic, users have run into their HVAD pump delaying or failing to restart, “including reports of 14 patient deaths and 13 cases where an explant was necessary,” the FDA explained. In addition, the FDA cited a “growing body of observational clinical comparisons” showing that patients who are implanted with the Medtronic device suffer a higher frequency of neurological adverse events, including stroke, and an increased mortality rate compared to patients given other commercially available left ventricular assist devices (LVADs).

In light of these reports, Medtronic is ceasing distribution and sale of the HVAD System and has issued an Urgent Medical Device Communication Notification letter to physicians requesting that they stop using the device. This action follows an earlier voluntary recall of a subset of HVAD pumps in December 2020 due to the same types of malfunctions cited in the FDA warning.

For now, the FDA is advising health care providers to follow Medtronic’s instructions in their notification letter, consider using alternative LVAD devices—for example, the Abbott Heartmate 3 Left Ventricular Assist System—and advise patients who currently have the HVAD system implanted to continue normal device use. Device explant is not recommended for these patients, Medtronic noted, and decisions about removing the HVAD pump “should be made on a case-by-case basis, with careful consideration of the patient’s clinical condition and surgical risk.

“We have been carefully monitoring the adverse events associated with this device and support its removal from the marketplace,” said Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, in a statement The FDA is working closely with both Medtronic and Abbott to ensure patient care is optimized during this transition period and that there is an adequate supply of devices available to provide this patient population with options for end-stage heart failure treatment.”

The FDA promised to keep health care providers and the public informed if new or additional information comes to light. In the meantime, the agency asked that any adverse events experienced with the Medtronic HVAD System be reported through the MedWatch reporting system.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 3

Topic ID: 74,3,184,730,3,914,192,725,925