This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.This information was received from the (b)(6) registry study.Product event summary: the ventricular assist device (vad) (b)(4) was not returned for evaluation.The reported suction event could not be confirmed via review of the controller log files since log files were not available for analysis.Information received from the site indicated that four days after the ventricular assist device (vad) implant procedure, the patient experienced ventricular tachycardia (vt) episodes associated with a suction event and they experienced atrial flutter.The patient was cardioverted one time and returned to native abib/flutter and they received intravenous (iv) medication.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, cardiac arrhythmia is a known potential complication associated with the implantation of a vad.There was no evidence that the patient had a history of similar adverse events.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.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.
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