The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-01612.This report is being submitted as additional information.Approximate age of device ¿ 1 day.A direct correlation between vad-62967, and the reported event cannot be conclusively established through this investigation.On 04-06-2018, the clinic reported that the patient underwent an outflow graft exchange on (b)(6)2018 due to the graft compressing the patient¿s right ventricle due to the patient¿s respiration.The patient underwent delayed chest closure on (b)(6) 2018 due to diffuse coagulopathy and right ventricular dysfunction.No further issues have been reported, and the patient remains ongoing on vad-62967.The hmii lvas ifu explains that physiological factors that affect the filling of the pump, and can result in reduced pump flows as long as the condition persists.The heartmate ii lvas ifu also outlines considerations for pump placement and provides instructions regarding the preparation, installation, and orientation of the sealed outflow graft.The ifu emphasizes that the graft must not be kinked or positioned where it could abrade against a pump component or body structure.This document instructs the user to stretch the graft completely, measure and cut the sealed outflow graft to the appropriate length, and then anastomose the graft to the ascending aorta.The hmii lvas ifu also lists right heart failure as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.Information regarding the recommended anticoagulation therapy and inr range is also provided in this document.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.Not returned.
|