TY  - BOOK
AU  - Bernardo, Nelson L
AU  - Chen, Yuefeng
AU  - Gallino, Robert
AU  - Garcia-Garcia, Hector M
AU  - Hashim, Hayder
AU  - Iantorno, Micaela
AU  - Kajita, Alexandre H
AU  - Khalid, Nauman
AU  - Khan, Jaffar M
AU  - Rogers, Toby
AU  - Shlofmitz, Evan
AU  - Torguson, Rebecca
AU  - Waksman, Ron
TI  - Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database
SN  - 1878-0938
PY  - 2019///
KW  - *Cardiac Catheters
KW  - *Coronary Artery Disease/dg [Diagnostic Imaging]
KW  - *Coronary Vessels/dg [Diagnostic Imaging]
KW  - *Tomography, Optical Coherence/is [Instrumentation]
KW  - Coronary Artery Disease/th [Therapy]
KW  - Databases, Factual
KW  - Equipment Design
KW  - Equipment Failure
KW  - Humans
KW  - Percutaneous Coronary Intervention/is [Instrumentation]
KW  - Predictive Value of Tests
KW  - Retrospective Studies
KW  - Risk Factors
KW  - Stents
KW  - Tomography, Optical Coherence/ae [Adverse Effects]
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N1  - Available in print through MWHC library: 2002 - present
N2  - 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; 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; Copyright (c) 2019 Elsevier Inc. All rights reserved; 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
UR  - https://dx.doi.org/10.1016/j.carrev.2019.03.009
ER  -