Two heart device manufacturers recently issued safety warnings regarding their devices due to several patient deaths. The first, Carmat, made the announcement after the first patient implanted with their artificial heart device passed away. A few days later, Thoratec Corp. alerted hospitals that at least four patients using a heart pump device have died.Defective medical device lawyers at Pintas & Mullins Law Firm report on these troubling new findings.
The Carmat patient was 76-years-old, and died 75 days after being fitted with the bioprosthetic heart. He required an artificial heart because he was suffering from terminal heart failure, and he was selected as the first patient to receive the Carmat device. Three more French patients with terminal heart failure are expected to soon receive the device, which is touted to last about five years.
Carmat estimates that over 100,000 patients in the U.S. and Europe could benefit from the artificial heart, believing it will save the lives of those waiting for donors. The company also believes it would reduce the severity of transplant side effects.
Currently, there is only one artificial heart device approved in the United States, made by SynCardia Systems. The longest period of time a patient has survived using that device was four years, at which time the patient received a heart transplant.
New Thoratec HeartMate Causing Trouble
The safety advisory sent to hospitals by Thoratec Corp. detailed deaths in patients implanted with its heart pump device, the HeartMate II. Another five patients either completely lost consciousness or suffered decreased blood flow.
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The problem with these pumps is in its switching controllers, which regulate the backup system and monitor the device’s performance. Like the Carmat device, the HeartMate II is implanted in patients with advanced heart failure. It is connected to an external battery pack and system controller, which alerts patients if battery life is running low.
All four deaths occurred while patients struggled to switch the HeartMate from its primary system to the backup system. Patients have to disengage the HeartMate to change controllers, and, if disengaged for too long, the device stops helping the heart pump blood.
Eight out of the nine patients that suffered an adverse event had been using the new version of HeartMate, which was introduced in May 2013. Company spokespeople noted that patients who had been using the earlier version may have trouble with switching the controllers, and urged patients and/or their caregivers to be retrained.
Two patient deaths occurred while the person was alone and failed to contact their hospital before switching. According to HeartMate’s labels, all patients are required to contact hospitals before they attempt to switch controllers.
Over 2,000 heart failure patients have received the newer HeartMate; and a study recently published in the New England Journal of Medicine found that there was an increased number of patients reporting blood clots after receiving the updated version.
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Our team of medical device attorneys is currently investigating cases of fatal injury from heart devices like the Thoratec HeartMate II. If you or someone you love was seriously injured or died as a result of a faulty medical device, contact our firm immediately. You may be able to receive compensation for your medical bills, emotional distress, or funeral expenses.
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