Medtronic has halted sale of the HeartWare Ventricular Assist Device System after more than 100 complaints were filed, including 14 reports of mortality.
The US Food and Drug Administration (FDA) has announced Medtronic, Inc. would cease sale and distribution of the HeartWare Ventricular Assist Device (HVAD) System and issued a warning to clinicians to stop new implants of the device.
Data show instances of internal pump delay or failure to restart had an association with increased risk of adverse events and mortality.
There were more than 100 complaints received by Medtronic, Inc. including 14 reports involving mortality and 13 patients requiring explant.
The company issued an Urgent Medical Device Communication Notification Letter to provide information for clinicians and patients.
The device was approved in 2017 for destination therapy as the world smallest centrifugal-flow VAD designed to reduce surgical invasiveness, improve recovery times, and enhance patient outcomes.
Approximately 2000 patients in the US and 4000 patients worldwide have been implanted with the HVAD system.
Prior to the decision to halt sale and distribution of the HVAD system, the company made a voluntary recall of a subset of the pumps In December 2020.
Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, noted in the FDA statement that 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,” Zuckerman said. “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 has called for clinicians to consider alternative systems and urged advisement to patients with the HVAD system to continue normal use and contact the company for replacement items.
“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,” Zuckerman continued.
Nnamdi Njoku, President of Mechanical Circulatory Support at Medtronic noted that safety and well-being of patients was their main concern.
“We know the greatest commitment we make to doctors and patients is to consistently make safe medical technologies that alleviate pain, restore health, and extend life,” Njoku said.
Both the FDA and Medtronic ask patients and clinicians to report adverse events or safety problems with the HVAD system to the FDA MedWatch Adverse Event Reporting Program.