Approximate age of device ¿ 5 years and 4 months. no device-related issues were identified through the evaluation of the returned pump.However, depositions were observed on several of the blood-contacting surfaces during the analysis.The pump was returned assembled with the driveline cut approximately 7.5 inches from the pump housing.The distal portion of the driveline was not returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned attached to the proximal pump port.The outlet elbow was returned attached to the distal pump port.The sealed outflow graft conduit was returned attached to the pump outlet elbow.The bend relief was returned not secured to the graft attachment.Examination of the sealed inflow conduit found depositions in the inlet tube and the inlet elbow.The depositions were thin, flat, and adhered to the textured surfaces.There appeared to be minimal occlusion of the blood flow path.The cause of the depositions could not be conclusively determined.The patient was reported to have been routinely transplanted and the deposition did not appear to have contributed to any device related issues.Examination of the sealed outflow conduit and pump blood contacting surfaces revealed no depositions or thrombus formations.Visual inspection of the pump bearings and bearing cups under a microscope found no anomalies related to wear or damage.Examination of the returned portion of the percutaneous lead found it to be unremarkable.Electrical continuity testing of the wires found no discontinuities or shorts.The pump was reassembled and operated on a mock circulatory loop and functioned as intended.Thrombosis is listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.
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