NYMC Faculty Publications
Modes of Failure with Fractional Flow Reserve Guidewires: Insights from the Manufacturer and User Facility Device Experience Database
Author Type(s)
Faculty
DOI
10.4330/wjc.v13.i7.223
Journal Title
World Journal of Cardiology
First Page
223
Last Page
229
Document Type
Article
Publication Date
7-26-2021
Department
Medicine
Abstract
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
RESULTS: Guidewire tip fracture was the most commonly reported mode of failure, in 174 (35.8%) cases followed by guidewire kinking (
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.
Recommended Citation
Khalid, N., Pandey, Y., Khalid, U., Kamran, H., Wermers, J. P., Chhabra, L., Alam, M., Jneid, H., & Kayani, W. (2021). Modes of Failure with Fractional Flow Reserve Guidewires: Insights from the Manufacturer and User Facility Device Experience Database. World Journal of Cardiology, 13 (7), 223-229. https://doi.org/10.4330/wjc.v13.i7.223
