It was reported that patient was admitted to the hospital with fever, right heart failure, hypotension and hypovolemia.Patient was diagnosed with sepsis.Also, had a drop in power and flow possibly due to thrombus.No further patient complications have been reported as a result of this event.
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The ventricular assist device (vad) was not returned for evaluation.The reported high power event was confirmed via review of the controller log files which revealed a slight increase in power consumption and estimated flows starting (b)(6) 2019.However, no alarms were logged for the past fourteen days leading up to (b)(6) 2019.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on historical review of similar high power events, the most likely root cause of the high power event can be attributed to external factors such as thrombus formation/ingestion.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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