It was reported that on (b)(6) 2020 the patient was admitted for high flows and high powers.The patient had a positive ramp study for a clot in their pump.The patient was admitted for shortness of breath and chest pain.The patient's log files were reviewed and found that flows were above normal parameters.This is usually caused by something in the rotor of the pump.The patient had aortic insufficiency, mild aortic valve regurgitation, trace mitral regurgitation, moderate tricuspid regurgitation, and mildly reduced right ventricular function during this event.Additionally, it was reported that the patient had labs done that indicated low hemoglobin and was transfused with 2 units of packed red blood cells.There were power and flow spikes on (b)(6) 2020.The patient also had a no external power event on (b)(6) 2020 that appears to have been the result of the patient simultaneously disconnecting power from both controller leads.The patient underwent a hmii to hmii pump exchange due to suspected vad thrombosis.The pump will be returned.
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Manufacturer's investigation conclusion: thrombus was confirmed in the evaluation of heartmate ii left ventricular assist system (lvas), serial number (b)(6).The pump was returned with the driveline cut approximately 6¿ from the pump housing and the distal end was not returned.The sealed inflow conduit (inlet tube, flex section, inflow elbow, and apical sewing ring) was not returned.The outlet elbow was returned attached to the outlet port, but the sealed outflow graft, bend relief, and bend relief collar were not returned.Upon disassembly of the returned pump, examination of the proximal side of the outlet stator revealed a non-laminated deposition surrounding the outlet bearing ball.The lack of laminated layering suggests that the deposition did not form within the outlet stator.Although its origin and duration of time for which the deposition was present in the pump cannot be conclusively determined, evidence of denaturation and circumferential contact marks on the outlet bearing cup suggest that the deposition was present in the outlet stator for an extended period of time while in operation.The deposition found in the device could have contributed to the reported elevated ldh.The deposition could have also potentially caused added friction on the spinning rotor, contributing to the reported power elevations.A correlation between the deposition and the reported drop in hgb and cr cannot be conclusively determined.Upon removal of the observed deposition, the device was cleaned.The pump's bearings, rotor, and blood-contacting surfaces were then examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline revealed no discontinuities or shorts.The pump was reassembled and functionally tested under normal operating conditions using a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values, comparable to what was recorded during the manufacturing process and the device functioned as intended.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The mod cable shipped on 02dec2014.The heartmate ii lvas instructions for use (ifu) is currently available.Section 1 of this ifu lists device thrombosis and bleeding as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.Section 6 "patient care and management" (under "pump performance monitoring") outlines indications of pump thrombosis as well as how to respond to such events.Section 6 (under "anticoagulation") also outlines the suggested anticoagulation regimen and inr range that should be maintained for patients using the heartmate ii lvas.No further information was provided.The manufacturer is closing the file on this event.
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