News | Ventricular Assist Devices (VAD) | August 06, 2015

FDA Issues Warning on Left Ventricular Assist Devices

Agency has received reports of pump thrombosis, stroke events and bleeding complications with HeartMate II and HeartWare HVAD devices

FDA, warning, LVADs, left ventricular assist devices, Thoratec, HeartMate II, HeartWare, HVAD

August 6, 2015 — The U.S. Food and Drug Administration (FDA) is alerting healthcare providers, patients and caregivers about serious adverse events associated with left ventricular assist devices (LVADs). These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices. The agency is also aware of bleeding complications associated with both devices.

Implantable LVADs help the left ventricle circulate blood throughout the body in patients with advanced heart failure. The devices consist of a blood pump, power pack and controller. The blood pump is implanted inside a patient’s body and attached to the heart’s left ventricle and to the aorta. The power pack and controller are connected to the blood pump and carried by the patient outside the body.

The FDA has received reports and information from a variety of sources indicating an increase in the rate of pump thrombosis events in patients implanted with the HeartMate II. Information also shows that patients are experiencing pump thrombosis events earlier than observed during the clinical trials conducted to support the product’s approvals in 2008 (bridge-to-transplant) and 2010 (destination therapy).

In regards to the HeartWare HVAD, the FDA is aware of recently reported results from a clinical trial designed to evaluate the safety and effectivness of the device when used for the DT indication. Investigators reported 28.7 percent of HVAD patients experienced one or more strokes over two years, compared to 12.1 percent among patients implanted with the control device (HeartMate II).

Both devices have raised concerns about bleeding complications through adverse event reports and information from a variety of sources. The cause of bleeding complications is not fully understood, but is likely due to many different factors. One possible factor may be modification to blood thinning (anticoagulation) therapy in an attempt to lower the risks of pump thrombosis and embolic stroke.

The FDA recommends the following actions for healthcare providers:

Perform a thorough clinical evaluation, assessing the benefit-risk profile of each patient in determining the most appropriate treatment plan and, if necessary, selecting a device;
Consider the risks for pump thrombosis, stroke and bleeding when determining the appropriate therapy for individual patients; and
Review the current device labeling prior to making treatment decisions if you are considering using either of these devices.

Return all explanted LVAD devices and components to their respective manufacturer. In the case of LVAD-related pump thrombosis and other adverse events, manufacturer evaluation of the affected device is critical to better understand the reasons for these adverse events.

The FDA has been working with Thoratec to better understand and explain the increased incidence of pump thrombosis. On Aug. 5, 2014, the FDA approved updated labeling for the HeartMate II that includes the risk of pump thrombosis. Thoratec is currently conducting a prospective, multi-center, non-randomized study designed to assess the incidence of HeartMate II pump thrombosis and to identify the risk factors associated with pump thrombosis events.

Thoratec was purchased by St. Jude Medical in July 2015.

Regarding the HeartWare HVAD, the FDA is concerned about the reported stroke rates, but at this time believes the benefits of using the device continue to outweigh the risk for the currently approved BTT indication. The agency also believes it is appropriate to continue the clinical investigation of this device in the DT population with the careful monitoring procedures currently in place. HeartWare is also currently conducting a prospective, randomized, controlled, un-blinded, multi-center study to assess whether optimal blood pressure management can help lower the incidence of stroke in DT patients implanted with an HVAD.

For more information: www.fda.gov


Related Content

News | Ventricular Assist Devices (VAD)

June 19, 2024 — When electrophysiologist Eugenio Cingolani, MD, isn’t seeing patients, he can usually be found in his ...

Home June 19, 2024
Home
News | Ventricular Assist Devices (VAD)

October 31, 2023 — Tenaya Therapeutics, Inc., a clinical-stage biotechnology company with a mission to discover, develop ...

Home October 31, 2023
Home
News | Ventricular Assist Devices (VAD)

June 7, 2023 — Magenta Medical Ltd. has announced the initiation of its FDA-approved Early Feasibility Study with the ...

Home June 07, 2023
Home
News | Ventricular Assist Devices (VAD)

March 1, 2023 — Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, today ...

Home March 01, 2023
Home
News | Ventricular Assist Devices (VAD)

November 2, 2022 — For decades, left ventricular-assist devices (LVADs) have extended the lives of people whose hearts ...

Home November 02, 2022
Home
News | Ventricular Assist Devices (VAD)

October 18, 2022 — The U.S. Food and Drug Administration (FDA) is providing updates to the FDA website to include ...

Home October 18, 2022
Home
News | Ventricular Assist Devices (VAD)

August 25, 2022 — The U.S. Food and Drug Administration (FDA) issued a statement that Medtronic, Inc. is recalling ...

Home August 25, 2022
Home
News | Ventricular Assist Devices (VAD)

August 5, 2022 — Black people and women with severe heart failure who might be good candidates for surgery to implant a ...

Home August 05, 2022
Home
News | Ventricular Assist Devices (VAD)

June 23, 2022 — Medtronic, Inc. is recalling a single lot of HeartWare HVAD System batteries due to welding defects that ...

Home June 23, 2022
Home
News | Ventricular Assist Devices (VAD)

June 8, 2022 — The U.S. Food and Drug Administration (FDA) has issued a release stating that Medtronic is recalling the ...

Home June 08, 2022
Home
Subscribe Now