Introduction
Adverse event reporting is essential for post-market surveillance and
risk assessment of medical devices, and can also serve as an indicator
of overall care patterns and device utilization. We have previously
communicated that the COVID-19 pandemic was associated with a
significant 46% decrease in weekly reported deaths attributed to
implantable cardioverter defibrillators (ICDs), and a significant 27%
decrease in weekly reported injuries attributed to coronary drug-eluting
stents.1 In addition, we have shown that the COVID-19
pandemic was associated with significant shifts in reported adverse
events for valve replacement and repair, in particular a 27% decrease
in weekly reported injuries attributed to non−allograft tissue heart
valves.2 This report assesses the impact of the
COVID-19 pandemic on the number of weekly reports of adverse events
attributed to three FDA cardiovascular medical device classes: cardiac
ablation percutaneous catheters; cardiac ablation percutaneous catheters
for treatment of atrial fibrillation; and cardiac ablation percutaneous
catheters for treatment of atrial flutter.