Adverse Events and Failure Modes Related to Impella RP/RP Flex: Insights From FDA MAUDE Database
Our analysis of the MAUDE database showed that device delivery issues, bleeding, and vascular complications accounted for a smaller proportion of reports with Impella RP Flex than with its predecessor. However, device-related thrombosis and pump malfunction accounted for a higher proportion of reports with RP Flex. These data do not reflect the overall incidence of complications, but instead highlight the need for physicians and other healthcare providers to return devices to the manufacturer for inspection when a failure occurs.
Authors
- Ron Waksman (ORCID: https://orcid.org/0000-0002-4063-9226)
- Marta Lorente‐Ros (ORCID: https://orcid.org/0000-0002-3081-9952)
- Ilan Merdler (ORCID: https://orcid.org/0000-0003-3294-5968)
- Abhishek Chaturvedi (ORCID: https://orcid.org/0000-0003-0241-2845)
- Kalyan R. Chitturi (ORCID: https://orcid.org/0000-0003-0602-2684)
- Toby Rogers (ORCID: https://orcid.org/0000-0002-6043-3137)
- Hayder Hashim (ORCID: https://orcid.org/0000-0003-2194-5428)
- Brian C. Case (ORCID: https://orcid.org/0000-0001-5355-9594)
- Ryan Wallace (ORCID: https://orcid.org/0000-0003-3662-2832)
- Itsik Ben‐Dor
Institutions
- MedStar Washington Hospital Center (US)
Publication Details
- Journal
- Catheterization and Cardiovascular Interventions
- Published
- 2024-12-11
- DOI
- https://doi.org/10.1002/ccd.31333
- Citations
- 2
- Primary Topic
- Venous Thromboembolism Diagnosis and Management
- Type
- article
- Field-Weighted Citation Impact
- 1.10