Modes of failure with fractional flow reserve guidewires: Insights from the manufacturer and user facility device experience database

Background: Fractional flow reserve (FFR) measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques. Robust real-world data on complications and modes of failure of FFR guidewires are limited. Aim: To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database for commonly used FFR guidewires. Methods: The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires [PressureWire™ X (Abbott), Comet™ (Boston Scientific), and Verrata™ (Philips)] by searching for the following events: "Injury", "malfunction", "death", and "other". This yielded 544 reports. After excluding incomplete reports, 486 reports were analyzed. Results: Guidewire tip fracture was the most commonly reported mode of failure, in 174 (35.8%) cases followed by guidewire kinking (n = 152, 31.3%), communication failure (n = 141, 29.0%), and shaft fracture (n = 67, 13.8%). In total, 133 (27.4%) device failures resulted in patient adverse events. The most common adverse event was retained guidewire tip, in 71 (53.4%) cases, followed by freshly deployed stent dislodgment (n = 26, 19.6%) and coronary artery dissection (n = 23, 17.3%). Seven deaths were reported. Conclusion: FFR guidewire failures can occur because of various mechanisms and cause patient adverse events. The MAUDE database serves as an important platform for improved collaboration among clinicians, device manufacturers, and regulators to improve device performance and optimize patient outcomes. Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.