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.