FDA Alerts Medical Professionals of Possible Medtronic Heartware Ventricular Assist Device (HVAD) System Defect On April 28, 2022, the U.S. Food and Drug Administration (FDA) issued a warning letter to medical professionals concerning a potential defect affecting Medtronic Heartware Ventricular Assist Device (HVAD) Systems. The alert states that if patients present pump thrombosis, their Medtronic Heartware Ventricular […]
On April 28, 2022, the U.S. Food and Drug Administration (FDA) issued a warning letter to medical professionals concerning a potential defect affecting Medtronic Heartware Ventricular Assist Device (HVAD) Systems. The alert states that if patients present pump thrombosis, their Medtronic Heartware Ventricular Assist Device could have a welding defect that is causing an internal pump malfunction. Medtronic also issued an Urgent Medical Device Correction letter to notify medical professionals of the Medtronic Heartware Ventricular Assist Device’s potential pump weld defect.
The FDA’s warning letter also recommends specific actions to take in order to care for patients who are implanted with a Medtronic Heartware Ventricular Assist Device System. The FDA reiterated its recommendation made in its June 2021 communication, which is not to remove properly functioning Medtronic HVAD Systems. Moreover, the decision to exchange or remove a Medtronic HVAD System should be decided on a case-by-case basis between medical providers and their patients.
Medtronic has also opened up an internal investigation to determine how the HVAD pumps could be affected.
The FDA’s warning letter states that patients who are suffering at least one of the following symptoms should be treated for pump thrombosis.
According to the FDA’s letter, should symptoms not resolve, the patient should be considered a “candidate” for a heart transplant, pump exchange, or pump explant for recovery, and after considering surgical risks and the patient’s clinical condition. Should patients have one or more of the signs and symptoms listed above, the treating physician should immediately submit all of the device’s controller .csv log files as explained in Medtronic’s Urgent Medical Device Correction.
The FDA also confirmed that its June 2021 communication recommendations had not been revised, including:
The Medtronic Heartware Ventricular Assist Device System is a stable left ventricular assist device (LVAD) that includes additional peripheral components, including:
In November 2012, the Medtronic Heartware Ventricular Assist Device System was approved for use in the United States. The device is approved as a treatment prior to heart transplantation in patients who have a risk for fatal left ventricular heart failure. The medical device is also used for heart tissue recovery and as a bridge therapy in patients who are not going to undergo heart transplantation in the near future.
So far, Medtronic has received three pump thrombosis complaints. These three complaints also identified an internal pump malfunction within the Medtronic HVAD System. In all three incidents, all three patients received pump exchanges. Two of the three patients tragically died after receiving a new pump.
The FDA continues to work with Medtronic to watch for adverse events connected with pump weld defects and to ensure that all current Medtronic HVAD implant patients receive follow-up monitoring. The FDA stated that the agency would continue to update the public and health care providers about any new or additional information as it becomes available.
The FDA is urging all medical providers to notify the FDA of any suspected adverse events connected to Medtronic HVAD Systems. The reporting of adverse events can be submitted online through the FDA’s MedWatch Safety Information and Adverse Event Reporting program. Immediate reporting of these adverse events helps the FDA pinpoint and better understand all risks associated with certain medical devices.
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