[HTML][HTML] Guide extension catheters: Review of technology and future directions

R Chava, SR Mekala, JK Kalavakunta… - Interventional …, 2023 - ncbi.nlm.nih.gov
Abstract Although Percutaneous Coronary Intervention (PCI) has revolutionized the
management of CAD, the deliverability of devices including balloons, specialty balloons …

Adverse events and modes of failure related to Impella RP: insights from the Manufacturer and User Facility Device Experience (MAUDE) database

N Khalid, T Rogers, E Shlofmitz, Y Chen… - Cardiovascular …, 2019 - Elsevier
Background/purpose Right ventricular (RV) mechanical circulatory support remains an
important adjunctive therapy for RV failure refractory to medical therapy. Impella RP …

[HTML][HTML] A systematic review of the quality of cardiovascular surgery studies that extracted data from the MAUDE database

B Ziapour, C Zaepfel, MD Iafrati, LB Suarez… - Journal of Vascular …, 2021 - Elsevier
Objective To investigate opportunities and limitations of using the Manufacturer and User
Facility Device Experience (MAUDE) database for cardiovascular surgery research, we …

Real‐world experience of suture‐based closure devices: insights from the FDA manufacturer and user facility device experience

BC Case, S Kumar, C Yerasi… - Catheterization and …, 2021 - Wiley Online Library
Objectives We analyzed post‐marketing surveillance data from the United States Food and
Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) …

Analysis of the food and drug administration manufacturer and user facility device experience database for patient-and circuit-related adverse events involving …

N Khalid, H Javed, SA Ahmad, JJ Edelman… - Cardiovascular …, 2020 - Elsevier
Abstract Background/Purpose We assessed commonly reported patient-and circuit-related
adverse events involving extracorporeal membrane oxygenation (ECMO) devices by …

Adverse events and modes of failure related to the FilterWire EZ Embolic Protection System: Lessons learned from an analytic review of the FDA MAUDE database

N Khalid, H Javed, T Rogers, H Hashim… - Catheterization and …, 2019 - Wiley Online Library
Objectives To assess the commonly reported complications and failure modes for FilterWire
EZ Embolic Protection Devices (EPD) by analyzing the postmarketing surveillance data from …

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

X Li, Y Feng, Y Gong, Y Chen - Journal of Patient Safety, 2024 - journals.lww.com
Objective This article aims to assess the reproducibility of Manufacturer and User Facility
Device Experience (MAUDE) data-driven studies by analyzing the data queries used in their …

Real-world experience of the Sentinel cerebral protection device: insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) database

BC Case, BJ Forrestal, C Yerasi, JM Khan… - Cardiovascular …, 2020 - Elsevier
Abstract Background/purpose The Sentinel Cerebral Protection System (Boston Scientific,
Marlborough, Massachusetts) is indicated for use as a cerebral protection device to capture …

Techniques to optimize the use of Optical Coherence Tomography: Insights from the manufacturer and user facility device experience (MAUDE) database

E Shlofmitz, HM Garcia-Garcia, T Rogers… - Cardiovascular …, 2019 - Elsevier
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 …

Adverse events and modes of failure related to rotational atherectomy system: the utility of the MAUDE database

N Khalid, H Javed, E Shlofmitz, Y Chen… - Cardiovascular …, 2021 - Elsevier
Background/purpose Coronary artery calcification is a marker of advanced atherosclerosis
and a predictor of adverse clinical outcomes. Rotational atherectomy (RA) can effectively …