Medtronic Offers Hospitals Backup Controllers to Help Prevent HVAD Failures

The unapproved software in the backup controllers has only been used twice to help prevent HVAD failures, and in one of those instances it failed and the patient was put into hospice care.

Medtronic has released modified software for backup controllers, which it says will help prevent problems with its Heartwear Ventricular Assist Device (HVAD) failing to restart, which has resulted in a number of recalls an resulted in serious injuries and deaths among individuals who had the heart pump implanted.

The Medtronic HVAD is used among patients who are risk of death from end-stage left ventricular heart failure, to help pump blood from the heart to the rest of the body. Typically the pump has been used while individuals are waiting for a heart transplant, but the HVAD has been plagued with problems.

While there are many life-saving benefits of Medtronic’s HVAD mobility, the devices have been subject to at least 17 Class I recalls over defective components since they were approved by the FDA in November 2012, and the agency removed the HVAD from the market in June 2021, after identifying more than 3,000 report involving patient deaths.

On October 13, Medtronic issued an urgent medical device communication (PDF) to health care professionals using HVAD systems. The letter indicates Medtronic is making a new algorithm available for backup controllers with modified software, which could be used in case the primary controller delays or fails to restart the HVAD system.

The announcement comes only a few months after the latest Medtronic HVAD recall issued in August 2022, due to a risk tha tthe batteries may fail unexpectedly and cause the device to shut off while supplying life-saving blood circulation therapy.

In March 2021, Medtronic issued another HVAD recall, following at least 19 serious injury reports that occurred after the devices failed to initially start, restart, or experienced a delay in restarting after the pump was stopped. The problem is believed to have contributed to at least two patient deaths.

This latest letter indicates the new algorithm for the backup controllers may address this problem and get the systems to restart.

“This communication is to notify you that Medtronic has developed an alternate pump start algorithm within the controller software that may help restart pumps for patients,” the Medtronic letter states. “Medtronic is now expanding availability of the algorithm to any healthcare provider with a patient of HVAD support, regardless of subset.”

Medtronic indicates the algorithm is already within the controller’s software, but that it is currently unapproved and there is limited testing. The company noted that some patients may have no other options if the standard controller fails to restart the pump. The letter warns that the unapproved software should only be used if the standard controller fails to restart the pump.

Medtronic is only aware of two instances where this technique was used. One was successful, but the other instance failed, and the patient was placed in hospice care.

Customers can request a controller with the unapproved software by sending an email request to rs.mcsmedicalaffairs@medtronic.com.

Medtronic HVAD Problems

Last summer, the FDA announced Medtronic was removing its HVAD systems from the market, due to an unreasonable risk of neurological events and increased death rates among patients. However, many individuals still had the device implanted, and the FDA did not recommend they have the Medtronic HVAD removed at the time, if there were no problems detected.

According to an August 2021 investigation by ProPublica, FDA inspectors began voicing concerns about Medtronic HVAD systems as early as January 2014, following a HeartWare recall in late December 2013, which was issued because the device could fail and stop pumping, leading to serious injury and death.

FDA investigators issued a warning letter a month later, after identifying a number of deficiencies at the HeartWare manufacturing facility in Miami Lakes, Florida, particularly involving the process for making sure that some corrections made to the HVAD actually work.

The ProPublica investigation lay the blame at the FDA’s feet, saying the agency allowed more than 19,000 patients to be implanted with the heart pump, most of whom received their implants after the FDA had determined the HVAD did not meet federal safety standards.

When the devices were removed from the market in June 2021, the FDA indicated it had received more than 3,000 reports of patient deaths by the end of 2020, all linked to HeartWare implant problems.