The FDA has yet another private listing of device-related deaths, this one for transcatheter aortic valve replacement (TAVR) devices that include Medtronic’s (NYSE:MDT) CoreValve and Edwards Lifesciences’ (NYSE:EW) Sapien 3 lines, according to a new report by Kaiser Health News.
Both devices were initially indicated for patients who were too frail or ill for open-heart surgery, but the FDA subsequently approved them for intermediate- and low-risk patients. TAVR devices are placed percutaneously, with a physician using a catheter to thread the device to the heart.
The FDA’s registry exemption program for TAVR-related adverse events is similar to its “alternative summary reporting” repository, which was inaccessible to the public and contained millions of medical device adverse event and malfunction reports. Once that repository’s existence was made public, the FDA released the information it contained.
The newly revealed registry was established in 2010 and contains adverse event reports that cover six devices, the FDA told Kaiser Health News. The report did not identify any devices other than those manufactured by Medtronic and Edwards, and the FDA did not immediately respond to a request for more information.
Such registries are maintained by medical societies, which “anonymize” them and share them with their members and the FDA but not with the public. This particular registry, known as the STS/ACC TVT Registry, is the main repository for clinical data related to TAVR devices. It was created by the Society of Thoracic Surgeons and the American College of Cardiology to monitor patient safety and real-world outcomes related to TAVR, according to its website.
The FDA accepts hundreds of death reports on spreadsheets from the STS/ACC TVT registry, according to Kaiser Health News. The news agency said that Medtronic’s CoreValve was the subject of more than reports of 5,800 deaths since 2014 and that spreadsheets from Edwards indicated 2,400 deaths since 2016, including individual reports on about 400 deaths.
This is not the first time that reporting by an STS/ACC registry to the FDA has been called into question. In October, a study published in JAMA Internal Medicine said that Abbott (NYSE:ABT) and Edwards may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices.
Medtronic told Kaiser Health News that when its devices malfunction, the company makes “every effort” to notify regulators, healthcare providers and the public in a timely manner. The company also said that about 40% of the deaths reported by the registry list no cause, making it difficult to determine if they were related to the device.
Edwards echoed Medtronic’s difficulty with determining whether deaths reported by the registry are directly related to its devices, the news agency reported. The company told Kaiser Health News that transcatheter valve surgery has benefited 600,000 patients worldwide, and that use of the Sapien 3 device in younger, healthier patients Sarah Huoh said that 600,000 patients worldwide have benefited from transcatheter valve surgery. She noted that use of the Sapien 3 valve healthier, younger patients was associated with a “remarkably low” 1% rate of death or disabling stroke a year after surgery.
You can read the Kaiser Health News report here.