Impella

Description of Event or Problem

Clinical Narrative:Impella 5.5 was inserted via right axillary artery graft site in a 54-year-old female patient presenting with Acute Myocardial Infarction and Cardiogenic Shock. The patient¿s comorbidities were not reported. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage D. Prior to pump insertion patient was supported by inotropes, vasopressors, and respiratory support.In the procedure room there was a drop in pump flows and suction when preparing to move the patient from the table to the bed for transport. The Transesophageal Echo (TEE) imaging probe was reinserted and a 1.2cm mass was observed at the pump inlet. Discussions were had regarding care and decision made to continue anticoagulation and monitor the pump. The physician did raise concerns of embolization of the mass during pump explant.Despite the indwelling mass the device functioned as expected, Performance Level P-6 with 3.9L/min flow with 5% Dextrose in water with sodium bicarbonate in the purge solution.After over 5 days of support the Impella 5.5 was weaned and explanted. No harm or injury was noted at the pump explant.

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.