TY  - BOOK
AU  - Bernardo, Nelson L
AU  - Chen, Yuefeng
AU  - Gajanana, Deepakraj
AU  - Hashim, Hayder
AU  - Iantorno, Micaela
AU  - Khalid, Nauman
AU  - Khan, Jaffar M
AU  - Musallam, Anees
AU  - Rogers, Toby
AU  - Shlofmitz, Evan
AU  - Torguson, Rebecca
AU  - Waksman, Ron
TI  - Adverse Events and Modes of Failure Related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database
SN  - 1878-0938
PY  - 2019///
KW  - *Heart Failure/th [Therapy]
KW  - *Heart-Assist Devices
KW  - *Product Surveillance, Postmarketing
KW  - *Prosthesis Failure
KW  - *Ventricular Dysfunction, Right/th [Therapy]
KW  - *Ventricular Function, Right
KW  - Databases, Factual
KW  - Heart Failure/di [Diagnosis]
KW  - Heart Failure/et [Etiology]
KW  - Heart Failure/pp [Physiopathology]
KW  - Humans
KW  - Prosthesis Design
KW  - Risk Factors
KW  - Time Factors
KW  - Ventricular Dysfunction, Right/di [Diagnosis]
KW  - Ventricular Dysfunction, Right/et [Etiology]
KW  - Ventricular Dysfunction, Right/pp [Physiopathology]
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N2  - BACKGROUND/PURPOSE: Right ventricular (RV) mechanical circulatory support remains an important adjunctive therapy for RV failure refractory to medical therapy. Impella RP (Abiomed, Danvers, MA) is approved for providing temporary RV support for patients with acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Robust data on the most commonly reported complications and failure modes for the Impella RP are lacking. We analyzed the post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to assess these endpoints; CONCLUSIONS: Findings from the MAUDE database highlight the failure modes of the Impella RP device that should be addressed in order to improve the device performance and obtain improved clinical outcomes when utilized for RVF; Copyright (c) 2019 Elsevier Inc. All rights reserved; MATERIALS/METHODS: The MAUDE database was queried for the time period January 1, 2009, through December 31, 2018, for Impella devices by Searching for the following event types: "injury", "malfunction", "death", and "other". The search yielded 436 device reports. Impella RP medical device reports were screened, and 35 reports were included for the final analysis; RESULTS: In cases of reported complications, Impella RP was placed most commonly for right ventricular failure (RVF) developing in postcardiotomy patients (20%). The most commonly reported complications included bleeding (42.9%) and vascular complications (22.8%). The modes of failure included damage or fracture of the device elements (34.2%); thrombus, or clot in the system (17.1%); and device detachment (8.6%)
UR  - https://dx.doi.org/10.1016/j.carrev.2019.03.010
ER  -