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Adverse Events and Modes of Failure Related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database.

MedStar author(s):

Bernardo, Nelson L

Chen, Yuefeng

Citation: Cardiovascular Revascularization Medicine. 20(6):503-506, 2019 06.PMID: 30922871Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Heart Failure/th [Therapy] | *Heart-Assist Devices | *Product Surveillance, Postmarketing | *Prosthesis Failure | *Ventricular Dysfunction, Right/th [Therapy] | *Ventricular Function, Right | Databases, Factual | Heart Failure/di [Diagnosis] | Heart Failure/et [Etiology] | Heart Failure/pp [Physiopathology] | Humans | Prosthesis Design | Risk Factors | Time Factors | Ventricular Dysfunction, Right/di [Diagnosis] | Ventricular Dysfunction, Right/et [Etiology] | Ventricular Dysfunction, Right/pp [Physiopathology]Year: 2019 ISSN:

1878-0938

Name of journal: Cardiovascular revascularization medicine : including molecular interventionsAbstract: 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%).All authors: Bernardo N, Chen Y, Gajanana D, Hashim H, Iantorno M, Khalid N, Khan JM, Musallam A, Rogers T, Shlofmitz E, Torguson R, Waksman ROriginally published: Cardiovascular Revascularization Medicine. 20(6):503-506, 2019 Jun.Original year of publication: 2019Fiscal year: FY2019 FY2019Digital Object Identifier:

https://dx.doi.org/10.1016/j.carrev.2019.03.010

Date added to catalog: 2019-06-21

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Title notes ( 6 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article		Available		30922871

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.

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%).

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