Impella

Description of Event or Problem

NSTEMI Patient waiting surgical consult severely decompensated and was brought urgently to Cath Lab to replace IABP for Impella. After IABP was removed, and Impella 14 Fr sheath was placed attempts to cross into left ventricle were unsuccessful. Physician proceeded to take picture of aortic root and observed significant aortic dissection. Procedure was aborted and patient was sent to ICU in grave condition.

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.