Real-World Adverse Events of Temporary Percutaneous Circulatory Support of the Right Ventricle - A Manufacturer and User Facility Device Experience (MAUDE) Analysis

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Authors

Joeita Macfield, Michigan State University College of Human Medicine Medical Student
Anjali Purohit, Michigan State University College of Human Medicine Medical Student
Ryan Grayburn, Corewell Health West
Jacob Gonzales, Corewell Health West
Nabin Manandhar-Shrestha, Corewell Health West
Scott Chicotka, Corewell Health West
Emily Seif, Corewell Health West
Brian Trethowan, Corewell Health West
Noah Jentzen, Corewell Health West
Renzo Loyaga-Rendon, Corewell Health West

Description

The Manufacturer and User Facility Device Experience (MAUDE), a mandatory FDA database was utilized for this study. Adverse events between September 2019 and January 2024 for Impella RP, Impella RP Flex and ProtekDuo systems were abstracted. The events were categorized as death, injury, malfunction, malfunction/injury.

Publication Date

5-9-2025

Disciplines

Cardiology

Recommended Citation

Macfield J, Purohit A, Grayburn R, Gonzales J, Manandhar-Shrestha N, Chicotka S, Seif E, Trethowan B, Jentzen N, Loyaga-Rendon R. Real-world adverse events of temporary percutaneous circulatory support of the right ventricle - A Manufacturer and User Facility Device Experience (MAUDE) analysis. Presented at: Research Day Corewell Health West; 2025 May 9; Grand Rapids, MI.

Comments

2025 Research Day Corewell Health West, Grand Rapids, MI, May 9, 2025. Abstract 1693