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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

    • Posted: 06/03/2019
    • Author:

      Nauman Khalid, Toby Rogers, Evan Shlofmitz, Yuefeng Chen, Anees Musallam, Jaffar M. Khan, Micaela Iantorno, Deepakraj Gajanana, Hayder Hashim, Rebecca Torguson, Nelson Bernardo and Ron Waksman

    • 2019CRM

    Highlights

    • Impella RP is approved for temporary RV support for acute right heart failure.
    • 35 reports from MAUDE database were included for the final analysis.
    • Most commonly reported complications included bleeding and vascular complications.
    • Most commonly reported failure mode was damage or fracture of the device elements.
    • Findings highlight failure modes that should be addressed to improve performance.

    Abstract

    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 deviceimplantation, 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.

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