New Recommendations on Use of Medtronic HVAD Heart Systems Issued For Patients With The Implant
Following thousands of reported deaths and a number of recalls issued in recent years, federal regulators have issued a series of new recommendations for individuals with an implanted Medtronic Heartwear Ventricular Assist Device (HVAD), which was removed from the market in 2021.
The Medtronic HVAD was previously used for individuals at risk of death from end-stage left ventricular heart failure, involving an implanted medical device intended 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. However, federal health officials do not recommend doctors remove the HVAD, unless an individual is experiencing problems. Therefore, many individuals face continuing risks from the device.
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On November 17, the FDA gave patients and healthcare professionals a list of new recommendations for HVAD systems.
“Choosing to remove an implanted Medtronic Heartware Ventricular Assist Device (HVAD) System without a medically necessary reason is not recommended at this time,” the FDA recommendations state. “The risks associated with removing an implanted Medtronic HVAD System are higher than the potential benefits. Decisions about removing or exchanging the Medtronic HVAD System should be made by patients and health care providers together, considering the patient’s clinical status and surgical risks.”
The FDA’s recommendations for patients included keeping their VAD coordinator aware of any concerns with the devices’ behavior, such as alarms, damage, power and battery issues, and even carrying case wear. It recommends they keep two sources of power connected to their controller at all times and to carry spare batteries, and a backup controller at all times.
Many of the recommendations for patients involve taking extreme care in handling, replacing, and monitoring of batteries and other power sources. The FDA indicates Medtronic will be allowed to continue to make replacement components for the devices, despite the recall.
The FDA is calling on doctors to make sure their HVAD patients are aware of those recommendations, as well as to be aware of the numerous communications, and medical device corrections Medtronic has released recently, such as modified software being available for backup controllers in case the primary controller fails.
The agency also recommends doctors check the device for wear and damage during clinical visits, and urges them to report any adverse or suspected events to the FDA’s MedWatch Adverse Event Reporting System.
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 have the device implanted, and the FDA does 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.
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