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

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    Author
    Khalid, Nauman
    Pandey, Yagya
    Khalid, Umair
    Kamran, Hassan
    Wermers, Jason P.
    Chhabra, Lovely
    Alam, Mahboob
    Jneid, Hani
    Kayani, Waleed Tallat
    Date
    2021-07-26
    Journal
    World Journal of Cardiology
    Publisher
    Baishideng Publishing
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.4330/wjc.v13.i7.223
    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™ 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.
    Keyword
    Adverse events
    Coronary guidewire
    Food and Drug Administration
    Fractional flow reserve
    Manufacturer and user facility device experience
    Modes of failure
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/16340
    ae974a485f413a2113503eed53cd6c53
    10.4330/wjc.v13.i7.223
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