This article has been updated with a response from Boston Scientific.
The FDA is apparently allowing medtech companies to submit incomplete reports of device-related deaths, according to a new report by the StarTribune of Minneapolis.
The news article says that the agency accepted one summary report covering four deaths related to Boston Scientific’s (NYSE:BSX) Watchman left atrial appendage closure device. The report contains no details about the events that led to the patients’ deaths nor about the postmarket surveillance study that revealed them. It refers only to a spreadsheet that the newspaper said the FDA declined to release.
The practice of allowing such reporting of patient deaths continues despite the agency’s action in June to discontinue the practice of accepting “alternative summary reports.” Medtech companies used these to report more than 1.1 million adverse events since 2016 without alerting the public.
More recently, JAMA Internal Medicine published a study that examined the misclassification of death reports by Edwards Lifesciences’ (NYSE:EW) and Abbott’s (NYSE:ABT) involving their transcatheter aortic or mitral valve replacement devices.
The study by JAMA Internal Medicine editor Dr. Rita Redberg, former FDA unique device identification (UDI) external program manager Madris Tomes and others examined a total of 10,558 adverse event reports related to Abbott’s MitraClip or Edwards’ Sapien 3 devices from the time the FDA approved them through December 2018.
An FDA official told the StarTribune that the secret Watchman reports “were part of a different summary reporting system that the FDA continues to operate – even though FDA officials are aware that granting such exemptions will lead to further non-public reporting of medical device events,” the newspaper said.
The agency also reportedly said that the exemption it grants to device registries does not excuse medtech companies from investigating and reporting adverse events revealed by those registries. However, an FDA spokesperson told the newspaper that if an outside entity conducts the postmarket surveillance, the device manufacturer would generally not be provided with all the details it needs to make a full adverse event report, including the patient’s name or that of the person who reported the event.
If the manufacturer obtains that information later, it must submit it to the FDA, the agency told the newspaper.
Boston Scientific’s website describes the Watchman as a permanent implant that is an alternative to the lifelong use of warfarin for people with atrial fibrillation not caused by a heart valve problem. The Watchman was designed to reduce the risk of stroke without the danger of bleeding associated with blood-thinners like warfarin.
“We take all patient safety and any potential product-related complications seriously, and are transparent and comprehensive with our reporting of events per established criteria set by the FDA,” the company said in an email to MassDevice. “Boston Scientific has a robust complaint reporting system and we report all relevant complaint information we receive in compliance with all FDA regulations. We do not withhold or keep in secret any relevant complaint information.
The company added that the FDA-mandated New Enrollment PoST Approval Surveillance Analysis Plan (NESTed SAP) embedded within the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion Registry (LAAO Registry) independently tracks all patients who have received a Watchman implant. The registry was established and is managed by the American College of Cardiology (ACC) and the data is available to ACC physicians to present or publish on any aspect of the registry, without Boston Scientific involvement.
“We are given access to only a subset of the data within the registry and made aware of potential post-market complaint information by means of a quarterly data export from the surveillance database,” Boston Scientific added. “The data Boston Scientific receives is limited and de-identified, with no further opportunity to obtain additional detail. When complaint criteria meets established FDA regulations for reporting, we report all relevant provided information to the FDA. All other Watchman events (e.g. those outside of the registry) are investigated and reported on an individual basis in compliance with FDA regulations.”
The company added that it has “a stringent internal monitoring and auditing system to ensure our devices are routinely assessed and aim to have the lowest possible rate of adverse events associated with our products. Further, post-approval studies/surveillance and real-world outcomes continue to demonstrate the Watchman implant is a safe, efficacious alternative to long-term warfarin therapy for patients with non-valvular atrial fibrillation to reduce their risk of stroke.”
More than 100,000 Watchman devices have been implanted worldwide, the company’s website notes. The FDA’s public MAUDE adverse-event database contains narratives about more than 40 death reports for the Watchman inf 2019, not including those in the summary report, the newspaper said.
The FDA nor Boston Scientific immediately responded to MassDevice’s requests for comment.