The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-01089.This report is being submitted as additional information.Approximate age of device - 4 years and 5 months.Device analysis: the evaluation of the returned explanted pump confirmed driveline damage that would have contributed to the reported alarms.The pump was returned assembled with the driveline cut approximately 2.5 inches from the pump housing and the distal portion was returned measuring 31 inches.An unfinished driveline repair was present approximately 16 inches from the pump housing, with the driveline replacement partially soldered to the existing driveline.The sealed inflow conduit and sealed outflow graft conduit were not returned.The outlet elbow was attached to its respective pump port.Upon disassembly, visual inspection of the pump blood-contacting surfaces revealed no evidence of adhered depositions or thrombus formations.Examination of the pump bearings, rotor, and blood-contacting surfaces under a microscope did not reveal any anomalies related to wear or damage.Examination of the proximal portion of the driveline revealed a tear approximately 2.5 inches from the system controller connector of the original driveline.Metal shielding breakdown was identified at the pump housing.Electrical continuity testing revealed intermittent discontinuity on the yellow wire.Examination of the underlying wires revealed an insulation breach on the yellow wire adjacent to the pump housing with the conductors partially exposed.The observed wire damage appeared to be the result of fatigue failure due to repetitive flexing at this location.This could have contributed to the partial breakdown of inner conductors of the yellow wire at this location.A partial fracture in the yellow wire would have been detected by the pocket controller when comparing wire currents, resulting in the observed driveline faults and corresponding yellow wrench advisories.The patient handbook contains a section on ¿caring for the percutaneous lead" and in addition, the instructions for use states all lvad percutaneous leads have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.The heartmate ii lvas ifu provides also outlines indications of driveline wire damage as well as how to respond to such events.In addition, the ifu outlines all system controller alarms as well as how to respond.No further information is available.The manufacturer is closing the file on this event.
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The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2013.It was reported that the patient presented to clinic for a routine follow-up.Upon system controller history interrogation a yellow driveline fault alarm appeared on the screen with no audible alarm reported.While the patient was sitting still, the alarm spontaneously resolved on the monitor without physically removing the alarm.The manufacturer¿s technical services representative reviewed the submitted log file and observed the drive line fault alarm was believed to be positive.On (b)(6) 2018, the customer reported there is one spot about 3-4 inches above the silver connector on the driveline where the white silicon is torn but the wires appear to be undamaged below.On (b)(6) 2018, a distal end percutaneous lead (driveline) replacement was performed; however, issues continued after the replacement.On (b)(6) 2018, the patient underwent a pump exchange.No additional information was provided.
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