FDA Issues Serious Adverse Event Warnings for Thoratec HeartMate II and HeartWare HVAD

Washington, DC: The US Food and Drug Administration (FDA) is alerting health care providers, patients, and caregivers about serious adverse events associated with LVADs. These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec' HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices.

Thoratec HeartMate II:

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' approvals in 2008 (BTT) and 2010 (DT). For example, two analyses in the scientific literature reported the confirmed (after explant) HeartMate II pump thrombosis rate as high as 8.4% of implanted devices at 3 months (Starling et al, 2013) and 6% of implanted devices at 6 months (Kirklin et al, 2014). This is compared to 1.6% of implanted devices at one year during the BTT clinical trial and 3.8% of implanted devices at 2 years during the DT clinical trial.

Pump thrombosis is a serious complication that can require repeat surgery to replace the pump or can lead to death.

HeartWare HVAD:

The FDA is aware of recently reported results from a clinical trial designed to evaluate the safety and effectiveness of the HeartWare HVAD when used for the DT indication. Investigators reported 28.7% of HVAD patients experienced one or more strokes over two years, compared to 12.1% among patients implanted with the control device (HeartMate II). Although the HVAD is not currently approved for DT, it is the same device approved for the BTT indication.

Stroke is a serious complication that can lead to permanent patient disability and death.

Thoratec HeartMate II and HeartWare HVAD:

The FDA is aware of bleeding complications related to both the Thoratec HeartMate II and HeartWare HVAD, 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.

Bleeding is a serious complication that can lead to death.

LVADs are approved for bridge-to-transplant (BTT) or destination therapy (DT). BTT refers to providing circulatory support to a patient at risk of imminent death from non-reversible left ventricular heart failure until a donor heart becomes available for a heart transplant. DT refers to providing circulatory support to a patient with end-stage left ventricular heart failure who is not candidate for a heart transplant.

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Last updated on Aug-5-15