The U.S. Food and Drug Administration (FDA) is alerting healthcare providers to the possibility that patients with the Medtronic Heartware Ventricular Assist System (HVAD) who appear to have pump thrombosis may have a defect solder in the internal pump, causing it to malfunction.
This week, Medtronic released an Urgent Medical Device Correction to notify healthcare providers of the pump solder defect. Medtronic is conducting an investigation to identify potentially affected HVAD pumps. The FDA is sending this letter to healthcare providers to ensure that you are aware of this defect and the recommended actions to take to manage the care of patients currently implanted with a Medtronic HVAD system. As stated in the June 2021 communication from the FDA, the FDA does not recommend elective removal of properly functioning systems. Decisions regarding removal or exchange of the Medtronic HVAD System should be made by healthcare providers and patients on a case-by-case basis, taking into consideration the patient’s clinical status and surgical risks.
- Patients with one or more of the signs or symptoms of pump thrombosis should be treated first for pump thrombosis.
- If symptoms do not resolve, then only determine if the patient is a candidate for pump exchange, heart transplantation, or pump explantation for salvage, taking into consideration the patient’s clinical status and surgical risks.
- If patients exhibit any of the signs and symptoms listed below, immediately submit all controller .csv log files as described in Medtronic’s Urgent Medical Device Correction section.
- Please note that the FDA recommendations from the June 2021 communication have not changed. Including:
- Follow the instructions provided in the Instructions for Use (IFU) and adhere to current best clinical practices, including strict management of blood pressure and International Normalized Ratio (INR), and the use of system log files to support clinical decision making related to pump performance.
- Discuss with patients that elective removal of an implanted Medtronic HVAD system is not recommended at this time. In general, the risks associated with explantation outweigh the potential benefits.
- Report any adverse events or suspicious events encountered with the Medtronic HVAD System through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
The Medtronic HVAD system is a durable left ventricular assist device (LVAD) that includes peripheral components (such as controllers, batteries, AC/DC adapters, carrying case) and has been approved for commercial use in United States in November 2012. It is approved as a gateway to heart transplantation in patients at risk of death from end-stage left ventricular heart failure, for cardiac tissue salvage, and as destination therapy in patients for whom heart transplantation is n is not planned.
Medtronic has received three patient complaints suspected of pump thrombosis, where inspection of returned pumps identified a malfunction in the internal pump of the Medtronic HVAD system. A pump exchange was performed for all three patients, and among these three patients, two patients died after the pump exchange. All three affected patients had one or more of the following signs or symptoms:
- Squeaking noise
- Transient power spikes on log files and high power alarms
- Elevated lactate dehydrogenase
- Low motor speed resulting in low perfusion
- Dizziness or dizziness
The FDA will continue to work with Medtronic to:
- monitor any adverse events related to pump welding defects.
- ensure that current patients with a Medtronic HVAD implant continue to receive appropriate follow-up care.
The FDA will keep health care providers and the public informed if new or additional information becomes available.
Reporting Issues to the FDA
The FDA encourages healthcare providers to report any adverse events or suspected adverse events encountered with the Medtronic HVAD System.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have any questions regarding this letter, contact the Division of Industry and Consumer Education (DICE).