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dc.contributor.authorKhalid, Nauman
dc.contributor.authorPandey, Yagya
dc.contributor.authorKhalid, Umair
dc.contributor.authorKamran, Hassan
dc.contributor.authorWermers, Jason P.
dc.contributor.authorChhabra, Lovely
dc.contributor.authorAlam, Mahboob
dc.contributor.authorJneid, Hani
dc.contributor.authorKayani, Waleed Tallat
dc.date.accessioned2021-08-09T13:52:14Z
dc.date.available2021-08-09T13:52:14Z
dc.date.issued2021-07-26
dc.identifier.urihttp://hdl.handle.net/10713/16340
dc.description.abstractBackground: 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.en_US
dc.description.urihttps://doi.org/10.4330/wjc.v13.i7.223en_US
dc.language.isoenen_US
dc.publisherBaishideng Publishingen_US
dc.relation.ispartofWorld Journal of Cardiologyen_US
dc.subjectAdverse eventsen_US
dc.subjectCoronary guidewireen_US
dc.subjectFood and Drug Administrationen_US
dc.subjectFractional flow reserveen_US
dc.subjectManufacturer and user facility device experienceen_US
dc.subjectModes of failureen_US
dc.titleModes of failure with fractional flow reserve guidewires: Insights from the manufacturer and user facility device experience databaseen_US
dc.typeArticleen_US
dc.identifier.doi10.4330/wjc.v13.i7.223
dc.source.volume13
dc.source.issue7
dc.source.beginpage223
dc.source.endpage229


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