Thoratec Corp., a mini heart pump manufacturing company, released an urgent safety advisory about the use of their pocket controller after four patients died and five others were injured due to the device’s use.
The notice, which included new labeling of their HeartMate II LVAS Pocket System Controller, noted that 2,142 patients were fitted with the device since August, 2012, and many experienced problems during the switch from a backup controller, or older version of the device to a new controller, or the device’s main system.
The controller, which helps operate the company’s ventricular assist device (LVAD), assists the unit in “taking over” for a failing heart.
Almost 5.1 million patients live with heart failure in the US alone, with more and more being added each day, as a growing number of individuals survive heart attacks, high blood pressure, and diabetes. Twenty percent of those with heart failure die within twelve months and the other half don’t make it more than five years.
The Thoratec corp reported that two of the deaths were due to patients changing the controller themselves, and upon inspection, the company could not find any problems with the controllers themselves. Eight of the nine occurred when changing from the pocket controller after the patient was trained on an older model.
“Consumers who have the HeartMate II LVAS Pocket Controller should immediately contact their doctor for retraining on use of the device and to receive updated patient handbook information,” the company said. “All patients using the Pocket Controller and their caregivers should be retrained on the use of the device and be provided with updated Patient Handbook information.”
If you have been fitted with a new pocket controller for the HeartMate II, it is important to understand how to operate the device and monitor yourself for potential warning signs for heart pump malfunctions. If you have any questions regarding operation of the device, consult your medical care provider immediately.
Rick Shapiro has practiced personal injury law for over 30 years in Virginia, North Carolina, and throughout the Southeastern United States. He is a Board-Certified Civil Trial Advocate by the National Board of Trial Advocacy (ABA Accredited) and has litigated injury cases throughout the eastern United States, including wrongful death, trucking, faulty products, railroad, and medical negligence claims. During his three-decade career, Shapiro has won client appeals before the VA Supreme Court, VA Court of Appeals, NC Supreme Court, SC Supreme Court, WV Supreme Court, TN Supreme Court, and three times before the United States Court of Appeals for the Fourth Circuit, underscoring Shapiro’s trial achievements. In addition, he and his law firm have won settlements/verdicts in excess of $100 million. His success in and out of the courtroom is a big reason why he was named 2019 “Lawyer of the Year” in railroad law in U.S. News & World Report's Best Lawyers publication (Norfolk, VA area), and he has been named a “Best Lawyer” and “Super Lawyer” by those peer-reviewed organizations for multiple years. Rick was also named a “Leader in the Law, Class of 2022” by Virginia Lawyers Weekly (total of 33 statewide honorees consisting of lawyers and judges across Virginia). And in September 2023, Rick was selected as a recipient of the National Board of Trial Advocacy (NBTA) 2023 President’s Award. Although many nominations were submitted from across the country, Rick was just one of eight attorneys chosen by the prestigious National Board which certifies civil trial attorneys across the U.S. Rick was also recently named to Virginia Lawyers Weekly 2024 Virginia’s Go To Lawyers Medical Malpractice. The attorneys awarded this honor are nominated by their colleagues and chosen by a panel from the publication.
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