Impella

Description of Event or Problem

An Impella 5.5 device was inserted into the left axillary/subclavian artery in a 55-year-old male patient presenting in acute decompensated cardiomyopathy. Prior to Impella support, the patient was classified as Society for Cardiovascular Angiography & Interventions (SCAI) stage C shock, and on multiple inotropes and vasopressors. The patient's comorbidities are unknown.After two months on support, while the patient was in the intensive care unit (ICU), tissue plasminogen activator (tPA) was proactively initiated and running as purge fluid. There were two low purge pressure (PP) alarms, which resolved on its own. No tubing leaks were observed. There was no noted interruption of flow or support for the patient. The tPA was utilized for the high PP to mitigate impact of biomaterial within the motor and there was no impact on the patient.The device continues to function as intended at performance (P) level P-6 at 3.9L/min with D5W Sodium Bicarbonate in the purge solution. The patient continues on support.

Additional Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 CFR, Part 803. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by Abiomed Inc, or its employees that the report constitutes an admission that the product, Abiomed Inc, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.