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Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database

Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database

Authors :
Hayder Hashim
Robert Gallino
Nauman Khalid
Toby Rogers
Nelson L. Bernardo
Yuefeng Chen
Hector M. Garcia-Garcia
Ron Waksman
Evan Shlofmitz
Alexandre H. Kajita
Rebecca Torguson
Micaela Iantorno
Jaffar M. Khan
Source :
Cardiovascular Revascularization Medicine. 20:507-512
Publication Year :
2019
Publisher :
Elsevier BV, 2019.

Abstract

Background/purpose Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality used to assess coronary arteries and as an adjunctive tool for optimization of percutaneous coronary interventions. Overall, the rate of complications and adverse events related to intravascular imaging is low. Limited data exist on the most commonly reported complications and modes of failure related to the use of OCT. Therefore, we analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess the reported complications and failure modes for OCT and reviewed techniques to optimize device use. Methods/materials The MAUDE database was queried for all event reports involving coronary OCT devices. Two independent reviewers identified 49 device reports included in the final analysis. Modes of failure and device-related patient complications were assessed. Results Of the 49 cases with reported device-related issues, 6.1% involved malfunction prior to insertion of the OCT catheter, and 30.6% of reported events did not result in an associated patient-related adverse event. The most commonly reported adverse events included coronary dissection and difficulty removing the catheter within a previously stented segment. No events of contrast-induced nephropathy were reported. Conclusions Findings from the MAUDE database highlight the modes of device-related events associated with OCT. Device issues are uncommon, and as a result, users should be aware of optimal techniques to prevent and minimize adverse events related to device use.

Details

ISSN :
15538389
Volume :
20
Database :
OpenAIRE
Journal :
Cardiovascular Revascularization Medicine
Accession number :
edsair.doi.dedup.....67ca8c2b7a57d505aa62adcc93fcf85e
Full Text :
https://doi.org/10.1016/j.carrev.2019.03.009