Miscategorization of deaths in FDA's adverse events database

Postmarketing studies and registries are a key source of information for FDA as it works to accelerate approval of medical devices, but researchers say current protocols for reporting adverse events (AE) are unreliable. They point to their study of AE reports for two high-risk interventional cardiac devices.

Postmarketing studies and registries are a key source of information for FDA as it works to accelerate approval of medical devices, but researchers say current protocols for reporting adverse events (AE) are unreliable. They point to their study of AE reports for two high-risk interventional cardiac devices. Within FDA's Manufacturer and User Facility Device Experience (MAUDE) database, the team flagged 9,320 injury and malfunction reports and 1,021 death reports for the Sapien 3 device since its approval in 2013 through the end of 2018. More than 217 of the injury and malfunction reports, however, indicated that the patient actually died during or after device implantation, meaning that misclassified reports accounted for 17.5% of total patient deaths. The investigators yielded similar results with the Mitra Clip device, which was approved in 2015 and has been the subject of 5,323 injury and malfunction reports in MAUDE and 295 death reports since then. A total of 97 injury and malfunction reports were misclassified, given that the patient had died, accounting for nearly one-quarter of the death total. The significant degree of miscategorization in the MAUDE database gives pause, according to the study authors, due to the subsequent underreporting of deaths. Coupled with talk of manufacturers reporting malfunctions in a hidden database, the investigators are concerned about inaccurate perceptions about the safety of medical devices and compromised decision-making as a result. Adverse event reporting must be improved, they conclude, in terms of both accuracy and clarity.