Impella

Description of Event or Problem

Impella RP Flex was inserted via left internal jugular in a 72-year-old female patient who was admitted for Coronary Artery Bypass Graft (CABG) surgery. The patient¿s documented comorbidities were coronary artery disease. The patient¿s clinical state prior to initiation of support was Society for Cardiovascular Angiography and Interventions (SCAI) Shock Stage C.While on support the device performed at lower than expected Performance (P)levels. P-9 to P-7 with average flows around 2.0 L/min with 5% Dextrose in water with sodium bicarbonate in the purge solution.Concerns of a Gastrointestinal (GI) bleed were noted on day two of support. The platelet lab value had dropped from 155/microliter of blood to 47/microliter of blood. The patients Hemoglobin and Hematocrit lab values were low at 9.5 and 26.3 respectively. Due to this the decision was made to reduce the systemic anticoagulation. It was noted the Anti-XA anticoagulation value was high at 0.9. Abiomed recommends trending Anticoagulation Time's (ACT) of 160 seconds to 180 seconds while on support.The patient clinical state continued to deteriorate and medical therapy was initiated along with the Impella support. Over the next two days it was noted that the SCAI shock stage continued to drop to D and E. After three days of support the decision was made to withdraw care.The death is most likely attributable to the patient's pre and post operative clinical condition with a SCAI shock stage E which has a known increased mortality rate. However, due to the persistent low flows on the Impella device it cannot be conclusively dissociated from the events as the low flows may result in ineffectively unloading the right ventricle causing venous congestion which could contribute to the GI bleed and subsequent patient deterioration.This complaint has been reviewed by the Associate Director of Post Market Clinical Review and the Medical Safety Office.

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.