[184163126]
(b)(6) study. It was reported that the patient experienced a transient ischemic attack. On (b)(6) 2019, a left atrial appendage (laa) closure procedure was performed. A watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used. The subject underwent successful placement of a 21 mm watchman laac device with complete laa seal and deployed device diameter of 18. 6 mm. Prior to the procedure, aspirin was administered and after the implant the subject was started on clopidogrel. The subject was discharged on (b)(6) 2019. On (b)(6) 2020, 316 days post index procedure, the subject had symptoms of dizziness, and worsened in a standing position. The subject had difficulty in equilibrium and seemed to be stumbling or off balance. Additional information received from their spouse revealed that the subject might have had a fall the previous day due to their imbalance but there was no head trauma or loss of consciousness. On the same day, the subject was hospitalized for further treatment and evaluation. In the emergency department, the subject was hypertensive and bradycardic but otherwise hemodynamically stable and was started on aspirin, lipitor and dapt therapy. The subject was evaluated for speech and swallow function and recommended expressive language training to improve ability to express wants and needs, and cognitive treatment to improve cognition. A magnetic resonance imaging (mri) was performed on the same day which revealed a punctate signal involving a left frontal gyrus which may reflect a subacute infarct. There were multiple foci of t2 and flair white matter subcortical and periventricular hyperintensities, non-specific but likely secondary to small vessel disease. On the same day a computed tomography (ct) head scan was performed which revealed no acute intracranial abnormality and no acute intracranial hemorrhage. At the time of evaluation, the subject was asymptomatic and there were no focal neurologic deficits. The subjects condition improved with the treatment. On (b)(6) 2020, the event was considered to be resolved and the subject was discharged on the same day.
Patient Sequence No: 1, Text Type: D, B5