It was reported that on (b)(6) 2023, a 25mm master series, vavgj was selected for an implant to replace the aortic root and ascending aorta.During the procedure, partial replacement of aortic root with graft of valved conduit hypothermic (30oc).The peripheral circulation of the patient was arrest and the patient also had antegrade bilateral selective head perfusion.Post procedure day 1, with neurological signs of hemiparesis of the right side.On (b)(6) 2023, a recanalization was performed relating to media infarction.Computer tomography showed media infarct of the left side with shifting to the right because of cardiac thromboembolism.On (b)(6) 2023, emergency craniotomy was performed to decrease the pressure on the left side of the brain.On (b)(6) 2023, echocardiogram revealed thrombi adherent to the 25mm master series,vavgj.The patient's activated clotting time (act) levels was act was < 90 at the time of icu admission, heparin was given.Antixa factor was 0.11 which represents therapeutically anticoagulation.It was also reported that the patient passed away on (b)(6) 2023 due to acute left ventricular failure without any ejection fraction after disabling stoke with craniotomy.
|
An event of stroke, hemorrhage, thrombus, embolism and patient death was reported.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the potential cause of the reported incident could be conclusively determined.However, field noted that patient death was due to acute left ventricular failure without any ejection fraction after disabling stoke with craniotomy.From medical review: the death was caused by the stroke and the need for a craniotomy in combination with the acute left ventricular failure.
|