Product event summary: a pump and an outflow graft with unknown serial numbers were not returned for evaluation.The reported high power event was not confirmed via review of the controller log files since log files covering the reported event date were not available for analysis.Of note, it was reported that vad and the outflow graft were exchanged.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the historical review of similar high power events, the most likely root cause of the high power event may be attributed to 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.Additional products: heartware ventricular assist system ¿ outflow graft, model #: unk, catalog #: unk, expiration date: unk, serial or lot#: unk, udi #: (b)(4), mfg date: unk, (b)(4).This event was reported in the q3 2020 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient was hospitalized with ventricular assist device (vad) power spikes, hemolysis, and subtherapeutic a nticoagulation.The ventricular assist device (vad) and outflow graft were exchanged.No further patient complications have been reported as a result of this event.This event was reported in the q3 2020 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.
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