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The FDA Database Where a Death Isn’t a ‘Death’

Many patient deaths may go uncounted by taking the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database at face value, researchers found.

A close look at the publicly available postmarketing medical device database turned up 17.5% of total patient deaths with Sapien 3 transcatheter aortic valve replacement having been misclassified as malfunction or injury — and it was worse for the MitraClip mitral valve repair device at 24.7%.

In many cases, event reports used words like “died” or “passed away” or “autopsy” even while listing these events as injury or device malfunction, according to the study published online in JAMA Internal Medicine by journal editor Rita Redberg, MD, MSc, of the University of California San Francisco, and colleagues.

Their discovery follows a Kaiser Health News report in March showing that the FDA had allowed device manufacturers to file reports of malfunctions in a hidden database. Such “alternative summary reporting” was then formally shut down by the agency in June.

“Both the miscategorization of deaths in FDA adverse-event reporting and hidden adverse-events reports can lead to inaccurate public and physician perception of the safety of medical devices and can compromise informed decision-making. Given the increased reliance on postmarketing surveillance, improving the accuracy and clarity of adverse-event reporting should be a high priority for both the FDA and industry,” Redberg’s team wrote.

“This is yet another study showing the inadequacy of the FDA device adverse-event reporting system. The FDA and others are actively seeking new approaches that can provide more timely, more accurate methods of ascertaining safety issues,” commented Harlan Krumholz, MD, of the Yale School of Medicine.

“For now, the current system, which is expensive and slow, fails to provide clinicians and patients with the information they need to make informed choices,” Krumholz told MedPage Today.

Adverse event reporting to MAUDE is mandated for manufacturers, importers, and device user facilities, although voluntary for physicians. Each event is categorized as a malfunction, injury, or death.

Redberg and colleagues had sifted through MAUDE reports from device approval — 2013 for the Sapien 3 bioprosthesis, and 2015 for MitraClip — out to the end of 2018.

Event reports probed by Redberg’s group totaled more than 10,000 for Sapien 3 and more than 5,500 for MitraClip.

The present findings do not warrant alarm over the use of these two devices in particular, suggested Danny Dvir, MD, of University of Washington Medical Center in Seattle.

“Our patients and the intervention community should mainly rely on the large data [set] that was accumulated in highest-standard prospective trials with independent safety monitoring boards and that included many thousands of patients using these devices. These studies did not reveal common major concerns,” he commented.

Dvir also stressed continued postmarketing surveillance via ongoing registries and MAUDE reports but noted that the latter do not include the total denominator of cases, thus making it impossible to estimate the magnitude of risk.

Redberg disclosed no conflicts of interest.


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