This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.Product event summary: the ventricular assist device (vad) (b)(4) was not returned for evaluation.The reported suction event was confirmed via review of the available autologs reports which revealed 48 suction alarms have been logged since (b)(6) 2020.Information provided by the site indicated that, in addition to the low flow event, the patient previously had a tracheotomy performed due to paralysis of both vocal cords after extubation.The vocal cords were completely fixed in the midline with severe glottic stenosis, and there was a risk of suffocation.The suction events were detected at the time of coughing due to sputum.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported suction event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.Per the instructions for use, respiratory dysfunction is known potential complication associated with the implantation of a vad.There was no evidence that the patient had a history of respiratory dysfunction.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, pha rmacological and procedural factors that may have contributed to this 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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