Related manufacturing reference: 3005334138-2020-00305, 2182269-2020-00067, 3008452825-2020-00354, 3008452825-2020-00355, 3005334138-2020-00307.Following an ablation procedure, a possible stroke and cerebral edema occurred.The ablation was completed successfully with no abnormalities.The patient was transferred to coronary care unit to be followed.The evening of the ablation procedure, assessment and investigation of acute ischemic stroke was administered.The following day, the patient withdrew from the clinical study.A ct on (b)(6) 2020 revealed a small caliber of distal m1 and decreased vascularities of the left side middle cerebral artery, compatible with acute occlusion of the m1 middle cer.The patient underwent a mechanical thrombectomy and was stabilized.A dyna-ct showed no obvious intracerebral hemorrhage (ich).The patient was followed in ncua.Altered mental status was noted and a brain ct showed brain edema without ich.Emergency decompressive craniectomy and icp insertion was administered.Prior to procedure, it was confirmed there was no thrombus and the active clotting time during the procedure was between 200 and 270.Though there is no indication a device caused the stroke or edema, the cause of the adverse events is unknown.There were no performance issues with any abbott device.
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