Methods
We used the Food and Drug Administration (FDA) Manufacturer And User Facility Device Experience (MAUDE) database, which lists reports from manufacturers, distributors, clinicians, and other voluntary reporters and is publicly accessible (2). We filtered the MAUDE data by device and adverse event type, examining ‘malfunction’, ‘injury’, and ‘death’ reports for all devices with the product code ‘NPT’ which is the FDA abbreviation for ‘percutaneous aortic valve prostheses.’ We analyzed adverse event reports for these devices from October 2012 to December 2021, as adverse events were first reported for percutaneous aortic valve prostheses in October 2012, and we were interested in the entire history of adverse event rates for percutaneous aortic valve prostheses. We performed paired t-tests for the differences between monthly reported adverse event types for each event type (death, injury, malfunction); we set p<0.05 as the cutoff for statistical significance.