A study published November 2013 in the New England Journal of Medicine finds a link between the HeartMate II, an implanted heart pump, and blood clotting problems. It’s generally used for patients with weakened hearts who aren’t candidates for heart transplants because of medical conditions or age. It is also used for patients awaiting a heart transplant.
In some of the patients who develop a blood clot, the device had to be replaced (sometimes more than once). For others, the damage was so severe that it necessitated a heart transplant. Tragically, 48.2 percent of the patients who developed a blood clot and didn’t receive a replacement or a heart transplant died.
At this time researchers have been not been able to pinpoint a cause. However, the issue didn’t start until March, 2011. In fact before this, the average time period for someone to develop a blood clot after it was implanted was 18.6 months. But after March 2011, blood clots started 2.7 months after implantation of the device.
It’s speculated that one possibility is changes made to the bearings in the pump by the manufacturer, Thoratec Corporation. Something else being taken into consideration is the speed setting on the pump; if it’s too low (and the blood is flowing slowly), it may allow a clot to develop.
Of course, it’s also possible that underlying health problems in the patients could be contributing factors. The U.S. Food and Drug Administration (FDA), which oversees medical devices, is aware of the problems. Although further research will be necessary in order to uncover the source, patients and doctors should be notified of the risks, according to the study authors.
When a medical device causes injury or death, patients and their families may file a product liability claim. These types of cases can focus on defects in the design and/or manufacturing process, or even improper marketing of a product. Contact Gacovino, Lake & Associates if you find yourself or a loved one harmed by a dangerous medical device – 800-550-0000.