Impella

Description of Event or Problem

An Impella RP Flex device was inserted via the right internal jugular vein in an 83-year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock, with a pre-support clinical condition consistent with Society for Cardiovascular Angiography and Interventions (SCAI) Stage E shock, as noted per patient flowchart. The patient was also receiving Impella CP support. The patient's medical history was notable for obesity.During the procedure, a hematoma developed near the right internal jugular Impella RP Flex insertion site. At the time of the bleeding event, the activated clotting time (ACT) was 300 seconds. Hemostasis was achieved with placement of a hemostatic suture. Due to the bleeding event and associated blood loss, the patient received two units of packed red blood cells.Care was later withdrawn, and the patient expired. The death is conservatively being reported; however, it is more likely attributable to the patient's underlying acute myocardial infarction, cardiogenic shock, and presenting SCAI Stage E.

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.