FDA Medical Device Reports May Significantly Undercount Patient Deaths: Study

While adverse event reports involving medical devices are often crucial in identifying products containing serious and potentially life threatening defects, a new study suggests nearly a quarter of all deaths linked to certain medical devices may not be reported accurately to federal regulators.

In a research letter published earlier this month in the medical journal JAMA Internal Medicine, researchers from the University of California San Francisco warn many patient deaths linked to medical devices appear to go unreported in the FDA’s adverse event database.

In the study, researchers looked at data on several medical devices involved in reports filed with the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. They used software to collate adverse event reports on two transcatheter valve devices, including the Sapien 3 and the MitraClip.

The researchers found numerous reports where patients were listed as “expired” or “passed away” but were misclassified as injuries or malfunction events. According to the findings, 217 of 1,238 patient deaths linked to Sapien 3, or 17.5%, were misclassified. The study also found that 97 of 392, or 24.7%, of patient deaths linked to the MitraClip were misclassified.

“We found a substantial misclassification of patient deaths in the FDA’s MAUDE database for the Sapien 3 and MitraClip devices, which resulted in the underreporting of deaths,” the researchers said. “Our findings raise concerns about the accuracy of adverse-event reports for high-risk devices. The results complement recent news reports that the FDA allowed device manufacturers to file reports of malfunctions in a hidden database, known as alternative summary reporting.”

The researchers said improving the clarity and accuracy of such reports should be a high priority for both the FDA and the medical device industry.

In June, the FDA announced it was releasing more than 6 million adverse event reports not previously seen by the public, which were part of a program known as the Alternative Summary Reporting (ASR) Program.

The announcement came following an investigative report by Kaiser Health News in May 2019, which revealed that the ASR program had allowed medical device manufacturers to file reports of medical device malfunctions and patient injuries to the ASR for years, instead of providing the information to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database, which is publicly accessible.

This means that those reports, which are required by law and often involve high-risk devices that could experience repeated reports of similar problems, were effectively hidden from public view.

The program granted exemptions to certain manufacturers for devices with well-known adverse events, allowing them to file those reports with the ASR on a quarterly basis. However, critics say that the program allowed many manufacturers to hide the scope of such problems by making it appear there were fewer incidents than there really were.