This article has been updated with comments from the American College of Cardiology.
The FDA said Thursday that it plans to make public information on four patient deaths linked to Boston Scientific’s (NYSE:BSX) Watchman heart implant once it receives that information from the company.
The agency said it has asked the sponsor of a Watchman postmarket study for details on the deaths so it can include that information in its MAUDE adverse-events database. A report Wednesday in the Minneapolis StarTribune said the FDA is apparently allowing medtech companies to submit incomplete reports of device-related deaths.
The news article said that the agency accepted one summary report covering four deaths related to Boston Scientific’s 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.
Boston Scientific 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, according to the company.
On Thursday, the FDA said in an email to MassDevice that it did share the spreadsheet with the newspaper. “There are no hidden reports,” said agency spokesperson Kristen Pluchino. “The manufacturer’s evaluation found that the device problems associated with the deaths are unknown and they were unable to draw conclusions.”
The agency said it granted Boston Scientific “an exemption from individual reporting requirements… for certain adverse events that the manufacturer becomes aware of through a qualified registry. The firm is still required to follow-up on events to the extent they are able and submit information through the form 3500A, which FDA redacts and makes available in MAUDE.”
Pulchino did not respond to a question about the types of adverse events the exemption covers.
Boston Scientific said Wednesday 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).
Although the FDA said the registry information is available to ACC physicians, an ACC spokeswoman said that is not the case. “NCDR is a way for hospitals, health systems and practices to measure and improve the quality of care. These groups who are enrolled in a registry have access to their own data and those who choose to publicly report can do so” through an ACC program that does not include the LAAO registry, she added. Researchers can also submit requests to NCDR for information that is based on NCDR data, the spokeswoman added.
All ACC NDR registries, including the LAAO Registry, “allow hospitals to confidentially participate in clinical quality-of-care benchmarking that is governed by institutional review board protocols,” the ACC added in an email to MassDevice today. Most clinical registries focused on quality-of-care, do not have permission from hospitals or patients to release the data publicly.
“ACC does recognize that registry benchmarking is of interest to patients who are making personal care decisions for themselves, therefore, ACC has established a voluntary public reporting program where hospitals can permit established benchmarks that are translated into ratings to be available for patients,” the cardiology society added. “Newer clinical care options, such as is captured in the LAAO Registry, typically require time to establish appropriate benchmarks that can be used in rating systems so are not yet available on the ACC’s FindYourHeartaHome.org public reporting site.”
The FDA also said that medtech companies do not report deaths or other adverse events related to devices through postmarket surveillance registries. Rather, registries notify manufacturers of adverse events and manufacturers are required to report such events to the FDA.
Under federal law, only manufacturers, device user facilities and importers are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. However, the FDA said it encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures.
This reporting method differs from the “alternative summary reports” (ASR) that the agency ended last year. Under the ASR program, manufacturers of certain devices could request an exemption from the requirement to file individual reports for certain events that were well-known and well-established risks associated with a particular device and to instead submit quarterly summary reports of such events. The agency said the ASR program allowed it to “more efficiently review reports of well-known, well-understood adverse events, so we could focus on identifying and taking action on new safety signals and less understood risks.”
Medtech companies used these to report more than 1.1 million adverse events since 2016 without alerting the public.
Registries do not generally provide manufacturers with the name of the patient or person who reported the event, so manufacturers cannot “conduct any meaningful follow-up for such events, regardless of whether events are reported individually or in summary format,” Pluchino said. Manufacturers who receive this exemption must submit information to the FDA on a specific form that must indicate the total number of events being summarized and the type of event.
“After being reviewed to redact information protected from disclosure, information from the 3500A report is made publicly available in MAUDE,” Pluchino said. “Additionally, the exemption does not impact the manufacturers’ responsibility to investigate based on available information and to report MDR-reportable events.”
