Yesterday Medtronic sent an Urgent Medical Device Communication letter to its customers, announcing that it is stopping the sale and distribution of its HeartWare Ventricular Assist Device (HVAD) System. The decision comes following a growing number of clinical comparisons that show “a higher frequency of neurological adverse events and mortality with the HVAD System as compared to other commercially available durable left ventricular assist devices (LVAD),” according to Medtronic’s letter.
Medtronic has received more than 100 complaints related to the delay or failure of the ability to restart the HVAD pump—this includes 14 patient deaths and 13 cases of a necessary device explantation. The device has been implanted in about 2000 U.S. patients and 4000 patients worldwide.
The company is advising physicians to immediately cease implantation of the product, but that explantation of the system inpatients who have the device is not recommended.
“The FDA’s highest priority is patient health and safety. We have been carefully monitoring the adverse events associated with this device and support its removal from the marketplace. 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,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in CDRH, in an agency news release. “The FDA’s alert is designed to quickly inform health care providers of this critical information so that patients with the current HVAD System continue to receive appropriate care and management.
In March, FDA announced a Class I recall of Medtronic’s HVAD pump implant, which is part of the HeartWare system.
Read Medtronic’s Urgent Medical Device Communication Notification Letter about the its HVAD System.
Read FDA’s letter to healthcare providers, “Stop New Implants of the Medtronic HVAD System”.