On June 8, 2022, the U.S. Food and Drug Administration (FDA) announced a Class 1 recall of Medtronic’s HeartWare Ventricular Assist Device (HVAD) system. The FDA classified the Medtronic HVAD recall as a Class 1 recall, the most serious type of recall, indicating that use of the device may cause serious injuries or death. According to an announcement published by the FDA in May 2022, Medtronic halted its sales and distribution of its HVAD system after identifying links to an increased risk of adverse neurological events and deaths in patients who use the medical device. The report states that the HVAD medical device can malfunction and fail to restart. Because the two issues can cause serious injuries or death, the Medtronic HVAD recall is Class 1.
The U.S. Food and Drug Administration is currently working with Medtronic to ensure the safety and health of device users remains a high priority. Current medical device users will continue to receive follow-up monitoring, and Medtronic will continue to meet its duties to assist patients and their health care providers. Moreover, the FDA affirmed that it was committed to providing essential updates about the affected HeartWare devices and the Medtronic HVAD recall, and would continue to provide updates to the public as new details become known.
What is a HeartWare Ventricular Assist Device (HVAD) System?
Heart failure is a serious, chronic medical condition that usually becomes worse over time and could result in end-stage heart failure and death. Patients who suffer end-stage heart failure will suffer severe symptoms such as painful swelling of the lower extremities, debilitating breathing difficulties, physical exhaustion, venous stasis that cause painful ulcers that do not heal, pulmonary edema, and abdomen edema. The Medtronic HeartWare Ventricular Assist Device system is a ventricular assist device that is often used in end-stage heart failure patients who are also waiting for a heart transplant. This use is known as bridge-to-transplant. The Medtronic HVAD System is also used with patients who have end-stage heart failure and who are ineligible or are too unwell to undergo a heart transplant or whose symptoms cannot be managed with medications, which is known as destination therapy. Destination therapy can help improve and extend a patient’s life. The Medtronic HVAD System supports the heart by assisting the weak left ventricle and by providing more blood flow.
The Medtronic HVAD System includes:
- A pump that is implanted in the area around the heart.
- A controller that manages the function and the speed of the pump.
- A tube is inserted into the heart to empty any blood.
- A tube is inserted into the aorta to assist the blood that is being pumped.
The HVAD’s controller stays outside the user’s body and is then attached to the pump using a flexible tube that passes through the user’s skin. The controller unit is powered by a power supply or batteries.
The Risks and Benefits of Medtronic’s HVAD System
In Medtronic’s previous benefit-risk assessments conducted in 2012 and 2017, Medtronic stated that the potential benefits of its HVAD System outweighed any risks. Medtronic also stated that its HVAD system’s benefits include:
- increased survival rate while on the medical device,
- the ability to position the HVAD pump without the need to create an abdominal pocket, and
- the ability to place the medical device inside of smaller patients as compared to the alternative devices.
Medtronic concedes the probable risks include neurological events, strokes, bleeding, major infection, right heart failure, and death. Medtronic states that the most probable side effects include strokes and other neurological events.
Patients who are currently implanted with Medtronic’s Medtronic HeartWare Ventricular Assist Device system, along with treating physicians, should follow all current FDA recommendations and the following guidance regarding the Medtronic HVAD recall :
- Doctors should remind their patients to keep spare batteries with them and keep two power sources connected to their device’s controller.
- Should a Power Disconnect alarm ring as a battery is being physically connected, that battery should not be used.
- Due to the possibility of a pump malfunction, as represented in Medtronic’s April 2022 Communication, patients suffering at least one symptom of pump thrombosis should be treated for pump thrombosis first.
- Physicians are urged to submit all controller .csv log files to Medtronic, as described in Medtronic’s April 2022 Communication, when a patient has one of the following symptoms:
- Grinding sound,
- Elevated levels of lactate dehydrogenase,
- Transient power spikes on the log files,
- High Watt alarms, and
- Low perfusion causes low motor speeds.
- If the pins on the Controller AC Adapter, DC adapter, or Battery connectors are dirty, do not clean the pins or use the device.
Removing the implanted Medtronic HVAD Systems is not recommended right now. Medtronic’s report states that the dangers associated with explant outweigh any potential benefits. Decisions about exchanging or removing the HVAD System need to be made on a case-by-case basis.
If you or a loved one has been harmed by a medical implant or device, contact Parker Waichman LLP for your free case review.
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