Description of Event or Problem · 1
(B)(6) STUDY. IT WAS REPORTED THAT A STROKE OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS NOT ADMINISTERED. ON (B)(6) 2019, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) WAS POSITIONED AND 27MM WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. THE DEVICE WAS SUCCESSFULLY IMPLANTED WITH A COMPLETE SEAL AND A DEPLOYED DEVICE DIAMETER OF 19 MM. ON (B)(6) 2019, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. AT THE 3 MONTH AND 12 MONTH FOLLOW-UPS IT WAS NOTED THE LAA SEAL WAS COMPLETE AND JET SIZE WAS LESS THAN OR EQUAL TO 5MM. ON (B)(6) 2020, 403 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT OF AN OUTSIDE HOSPITAL DUE TO COMPLAINTS OF UNABLE TO STAND AND SUPPORT WITH THE LEFT ARM. THE SUBJECT WAS FEELING TINGLING IN THE LEFT HAND AND BURNING SENSATION IN THE SOLES OF THE FEET. THE SUBJECT WAS NOTED TO HAVE DISTAL ARM PARESIS ON THE LEFT, HYPERESTHESIA AND HYPERALGESIA IN THE REGION OF THE LEFT ARM. THE SUBJECT WAS HOSPITALIZED ON THE SAME DAY. AT THE TIME OF THE EVENT, THE SUBJECT WAS TAKING ASPIRIN. A NEUROLOGICAL ASSESSMENT, AND A CT SCAN WITH CT ANGIOGRAPHY AND PERFUSION WERE FORMED. THE CT SCAN REVEALED NO EVIDENCE OF ANY NEW-ONSET INTRACRANIAL BLEEDING OR AN ACUTE INFARCT DEMARCATION, NO PERFUSION DEFICIT AND NO VESSEL OCCLUSION. ON (B)(6) 2020 AN MRI OF THE SKULL WAS PERFORMED WHICH REVEALED EVIDENCE OF MULTIPLE BILATERAL MICROBLEEDS. THE EXISTENCE OF AMYLOID ANGIOPATHY WAS DEEMED TO BE UNLIKELY IN THE NEURORADIOLOGICAL VISITS. ON (B)(6) 2020, EXTRACRANIAL AND TRANSCRANIAL DUPLEX ULTRASOUND WAS PERFORMED WHICH REVEALED SIGNS OF GENERALIZED MACROANGIOPATHY, AT MOST, MINOR STENOSIS OF THE RIGHT INTERNAL CAROTID ARTERY IN THE BIFURCATION AREA (MAX 20% ACCORDING TO NASCET) WITH NO HEMODYNAMIC RELEVANCE TO THE DOWNSTREAM VESSEL SEGMENTS. IN ADDITION, THERE WERE NORMAL FINDINGS OF THE EXTRACRANIAL AND INTRACRANIAL VESSELS SUPPLYING THE BRAIN. THE SUBJECT WAS DIAGNOSED WITH ISCHEMIC STROKE. THE DURATION OF FOCAL OR GLOBAL NEUROLOGICAL DEFICIT WAS LESS THAN 24 HOURS IN CASE OF IMAGING-DOCUMENTED NEW HEMORRHAGE OR INFARCT. THE SUSPECTED CAUSE WAS NOTED AS MOST LIKELY CARDIOEMBOLIC IN ATRIAL FIBRILLATION. THE SUBJECT WAS STARTED ON ORAL ANTICOAGULATION WITH DABIGATRAN. ON (B)(6) 2020, THE EVENT WAS CONSIDERED RESOLVED WITH SEQUELAE AND THE SUBJECT WAS TRANSFERRED TO THE SPECIALIST CLINIC ON THE SAME DAY FOR FOLLOW-UP TREATMENT.