Abstract 16169: Modes of Failure and Patient Adverse Events of Fractional Flow Reserve Guidewires: Insights From the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database

Abstract

Introduction: Fractional Flow Reserve (FFR) measurement is commonly used in the cardiac catheterization laboratory to assess functional significance of coronary arterial plaques. Robust real-world data on complications and modes of failure of FFR guidewires are limited. We analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to report these endpoints for commonly utilized FFR guidewire. Methods: MAUDE database was queried from January 1, 2010, to April 1, 2020, for 3 commonly used FFR guidewires (PressureWire TM X (Abbott), Comet TM (Boston Scientific) and Verrata TM (Philips)) by searching for following events: “injury”, “malfunction”, “death”, and “other” yielding 544 reports. After excluding incomplete reports and older devices not in current use, 486 reports were analyzed. Results: Figure 1 shows reported modes of failure and patient adverse events. Guidewire tip fracture was the most reported mode of failure in 174 (35.8%) cases. Guidewire kinking (n= 152 (31.3%)), communication failure (n= 141 (29.0%)), and shaft fracture (n= 67 (13.8%)) were also reported. 133 (27.4%) of total device failures resulted in patient adverse events. Most common patient 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%)) respectively. 6 patient deaths were reported. Conclusions: FFR guidewire failures can occur due to a variety of mechanisms and lead to patient adverse events. MAUDE database serves as an important platform for improved collaboration between clinicians, device manufacturers, and regulatory bodies to improve device performance and optimize patient outcomes. Our analysis provides insights into the mechanism of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.