Temporary Non-Roller Type Left Heart Support Blood Pump

Description of Event or Problem

Clinical Narrative:Impella CP was inserted via right femoral access site in an Asian male of unknown age for Acute Myocardial Infarction/Cardiogenic Shock . The patient¿s comorbidities were not available. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage D, requiring Inotropes/Vasopressors, and Respiratory support prior to and during Impella support.The Impella 0.018' wire was removed from the sterile packaging and reported to be shaped as recommended prior to insertion, with no noted abnormal bends/kinks visualized prior to insertion. When attempting to remove the wire from the Impella after delivery of the pump into the left ventricle, the wire became stuck. The provider subsequently removed the device with wire in place as a result. The wire was reported to appear stuck in the outlet portion of the Impella, however the provider was able to remove it from the Impella, once out of the body. The wire was noted to appear damaged/abnormal upon visualization after removal.The Impella CP was re-inserted using a non-specified, non-Abiomed wire without incident. The device was initiated and supported the patient at a performance level of 8 with flows of 3.5lpm, for just over 3 days before the patient expired while on support.The delay to therapy that occurred as a result of being unable to remove the Abiomed 0.018" wire, requiring a second, non-Abiomed wire to be utilized to deliver the Impella CP, is being reported as a contributing factor in the patient death, as it cannot be ruled out based on the available information.

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.