Reported Device Failure and the Coronavirus Pandemic: Cardiovascular Interventions

Regular cardiology practices were interrupted by the COVID-19 pandemic. To better understand the pandemic’s effects on cardiology practices, we investigated whether the pandemic affected reporting of cardiovascular medical device failure by examining whether adverse event reports per week attributed to different cardiovascular devices changed significantly during the pandemic. By using data from FDA’s MAUDE database, we compared weekly rates of adverse event reports over the course of three years attributed to each of four devices: ‘Implantable Cardioverter Defibrillator (Non-CRT)’, ‘Coronary Drug-Eluting Stent’, ‘Aortic Valve, Prosthesis, Percutaneously Delivered’, and ‘Heart Valve, Non-Allograft Tissue’. Specifically, we looked at trends per week for the adverse events 'Malfunction’, ‘Injury’, and ‘Death’ for March 2018-March 2019, the pre-pandemic year of March 2019-March 2020, and the pandemic year March 2020-March 2021. We report a 46% decrease in reported deaths attributed to ICDs, a 27% decrease in reported injuries attributed to coronary DES, a 107% increase in reported deaths and a 45% increase in reported malfunctions attributed to percutaneous aortic valve prostheses, as well as a 27% decrease in reported injuries attributed to non-allograft tissue heart valves (all comparisons pandemic to pre-pandemic). That these four cardiovascular medical devices did not homogeneously increase or decrease suggests that changing care patterns that differently affected each device were the root of these trends, rather than a broader factor like underreporting which one would expect to affect the devices similarly.