Adverse Events and Failure Modes Related to Impella RP/RP Flex: Insights From FDA MAUDE Database.

BACKGROUND

Impella RP and RP Flex can provide right ventricular (RV) support in numerous clinical situations. Notably, the redesigned RP Flex allows for an internal jugular approach compared to the femoral venous approach with RP.

AIMS: We investigated the type and frequency of device-related complications as reported in the US Food and Drug Administration (FDA) Manufacturer and User Facility Experience (MAUDE) for both Impella RP and RP Flex to see if there are any differences.

METHODS

The MAUDE database was accessed from January 1, 2019 to April 30, 2024, yielding 206 reports pertaining to Impella RP and 64 to RP Flex. Reports were reviewed for device indications, mode of device failure, and device-related complications.

RESULTS

The most common indication for Impella RP placement was acute myocardial infarction with RV failure. The most commonly reported failure mode was pump failure. Death was reported in 8.5% and vascular complications in 3.7% of the reports. The most reported device-related complication was hemolysis (18.5%), followed by bleeding requiring transfusion (14.1%), with new dialysis occurring in 3.3% of patients.

CONCLUSIONS

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.