Description of Event or Problem · 1
(B)(6) STUDY. IT WAS REPORTED THAT A CEREBRAL VASCULAR ACCIDENT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A 35MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM WERE USED. THE DEVICE WAS PLACED AND THE PROCEDURE COMPLETED SUCCESSFULLY. ON (B)(6) 2021, 92 DAYS POST PROCEDURE, THE PATIENT EXPERIENCED EXPRESSIVE AND RECEPTIVE APHASIA, RIGHT ARM TINGLING AND DYSARTHRIA. THE PATIENT PRESENTED AT THE EMERGENCY DEPARTMENT WITH RIGHT UPPER EXTREMITY PARESTHESIA. USE OF A TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS PLANNED AS THE PATIENT HAD NOT BEEN ON AN ANTICOAGULANT FOR THE WEEK AND A HALF PRIOR. THE CESSATION OF ANTICOAGULANT PRIOR TO THE EVENT WAS A PROTOCOL OF THE CHAMPION CLINICAL TRIAL THE PATIENT WAS ENROLLED IN. ON THE DAY OF ADMITTANCE TO THE EMERGENCY DEPARTMENT, THE NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) SCORE OF THE PATIENT ROSE FROM 3 TO 7. THE TPA WAS ADMINISTERED AND THE PATIENT WAS ADMITTED TO THE NEUROLOGICAL INTENSIVE CARE UNIT (ICU) FOR FURTHER EVALUATION. A COMPUTED TOMOGRAPHY (CT) ANGIOGRAM WITH AND WITHOUT CONTRAST REVEALED A LEFT M3 BRANCH OCCLUSION OF THE MIDDLE CEREBRAL ARTERY (MCA). A MODERATE REGION OF THE LEFT MCA TERRITORY REVEALED ISCHEMIA WITHOUT COMPLETE INFARCTION. THE CT SCAN DEMONSTRATED A MODERATE REGION OF ISCHEMIA IN THE LEFT MIDDLE CEREBRAL ARTERY TERRITORY INVOLVING PORTIONS OF THE LATERAL PARIETAL LOBE EXTENDING INTO THE OPERCULUM. THE CT SCAN ALSO REVEALED NO ACUTE INTRACRANIAL HEMORRHAGE, NO INTRA OR EXTRA AXIAL MASS EFFECT, THE VENTRICULAR SYSTEM WAS UNREMARKABLE AND THE BASILAR CISTERNS AND CALVARIUM WERE INTACT. ADDITIONALLY, THE CT SCAN INDICATED THE ORIGIN OF THE BRACHIOCEPHALIC VESSELS, AND COMMON AND CERVICAL PORTIONS OF BOTH INTERNAL CAROTID ARTERIES WERE ALL PATENT. THE VERTEBROBASILAR SYSTEM WITH CONCOMITANT VERTEBRAL ARTERIES WERE ALSO NOTED TO BE PATENT. AT THE TIME OF THE EVENT, THE PATIENT WAS TAKING 81MG OF ASPIRIN AND WAS PRESCRIBED FLUOXETINE 20MG DAILY. THE FOLLOWING DAY, (B)(6) 2021, CHEST RADIOGRAPHS REVEALED THE PRESENCE OF A PACEMAKER AND AN ABSENCE OF EFFUSION, PNEUMOTHORAX OR ANY CARDIOPULMONARY DISEASE. A RIGHT SIDED AUTOMATIC IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (AICD) WAS NOTED AND THE WATCHMAN DEVICE WAS OBSERVED IN SATISFACTORY POSITION. A FOLLOW UP CT SCAN WITHOUT CONTRAST REVEALED NO EVIDENCE OF ACUTE INTRACRANIAL HEMORRHAGE, MASS EFFECT, MIDLINE SHIFT, EXTRA AXIAL FLUID COLLECTION OR ACUTE TERRITORIAL INFARCT. VENTRICLES AND SULCI WERE NORMAL IN APPEARANCE FOR THE AGE OF THE PATIENT. THE BASAL CISTERNS WERE PATENT, THE CALVARIUM WAS GROSSLY INTACT AND THE PARANASAL SINUSES AND MASTOID AIR CELLS WERE WELL PNEUMATIZED. THERE WAS AN ABSENCE OF ADENOPATHY, PLEURAL OR PERICARDIAL EFFUSION, THORACIC AORTIC ANEURYSM OR DISSECTION AND MASSES. PATENT CENTRAL AIRWAYS WITHOUT EVIDENCE FOR ENDOBRONCHIAL LESIONS WERE ALSO NOTED. THERE WAS NO EVIDENCE OF DEVICE RELATED THROMBUS ON THE ATRIAL ASPECT OF THE DEVICE OR PERICARDIAL EFFUSION. THE DAY FOLLOWING ADMITTANCE TO THE ICU THE MODIFIED RANKIN SCALE (MRS) OF THE PATIENT WAS 1, INDICATING NO SIGNIFICANT DISABILITY. AT THAT TIME THE PATIENT EXPERIENCED OCCASIONAL MILD RESIDUAL APHASIA. ON (B)(6) 2021, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED THE WATCHMAN FLX DEVICE WAS APPROPRIATELY SEATED WITH NO THROMBUS AND NO RESIDUAL SHUNTING. ON (B)(6) 2021, FIVE DAYS AFTER ADMITTANCE TO THE ICU, A MAGNETIC RESONANCE IMAGING SCAN (MRI) WITHOUT CONTRAST REVEALED SMALL AREAS OF RECENT INFARCT INVOLVING THE LEFT MCA TERRITORY INCLUDING THE INSULA, POSTERIOR FRONTAL AND PARIETAL LOBES. HOWEVER, NO HEMORRHAGIC TRANSFORMATION OR HERNIATION WAS NOTED. THE PATIENT WAS DISCHARGED THAT DAY WITH PRESCRIPTIONS FOR ASPIRIN, 81 MG, AND APIXABAN 5MG, AN ANTICOAGULANT. THERE WILL BE A FOLLOW UP MRS COMPLETED 90 DAYS PAST THE EVENT.