WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
Report
- Report Number
- 2134265-2022-01987
- Event Type
- Injury
- Date Received
- February 24, 2022
- Date of Event
- February 3, 2022
- Report Date
- January 27, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 08714729860518
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: DESCRIBE EVENT OR PROBLEM: UPDATED AND CORRECTED. B6: RELEVANT TESTS/LABORATORY DATA: UPDATED. H6: PATIENT CODES: UPDATED. H6: IMPACT CODES: UPDATED.
H3: DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A 31MM WATCHMAN FLX IMPLANT ONLY IN A SEALED JAR OF BLOOD-TINGED LIQUID. THERE WAS BLOOD AND TISSUE ON THE OUTSIDE AND INSIDE OF THE DEVICE. INSPECTION OF THE FABRIC, ANCHORS AND STRUTS REVEALED NO DAMAGE OR DEFECT. PRODUCT ANALYSIS AND THE PATHOLOGY REPORT CONFIRMED THE REPORTED EVENT AS THERE WAS THROMBUS PRESENT ON THE IMPLANT. THERE WAS NO OTHER DAMAGE OR DEFECT FOUND ON THE REMAINDER OF THE IMPLANT.
THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2021 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN (81MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE(LAA) CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2021 WITH SUCCESSFUL PLACEMENT OF A 31 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26.0 MM. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND WARFARIN. ON (B)(6) 2022, 121 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA-IMAGING AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 60% AND COMPLETE SEAL WITH A PEDUNCULATED, NON-MOBILE WITH MAXIMUM AREA OF 7.2 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE AND ALSO PRESENCE OF NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 7.2 CM2, 3.8X3.1CM OVERLYING THE WATCHMAN DEVICE IN THE LEFT ATRIUM. HOWEVER, THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT. IN RESPONSE TO THE EVENT, CARDIOTHORACIC SURGERY WAS PERFORMED. ON (B)(6) 2022, THE EVENT WAS CONSIDERED RESOLVED.
THE SUBJECT WAS ENROLLED IN THE CHAMPION-ATRIAL FIBRILLATION STUDY ON (B)(6) 2021 WITH SUBJECT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN (81MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE(LAA) CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2021 WITH SUCCESSFUL PLACEMENT OF A 31 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26.0 MM. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND WARFARIN. ON (B)(6) 2022, 121 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA-IMAGING AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 60% AND COMPLETE SEAL WITH A PEDUNCULATED, NON-MOBILE WITH MAXIMUM AREA OF 7.2 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE AND ALSO PRESENCE OF NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 7.2 CM2, 3.8X3.1CM OVERLYING THE WATCHMAN DEVICE IN THE LEFT ATRIUM. HOWEVER, THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT. IN RESPONSE TO THE EVENT, CARDIOTHORACIC SURGERY WAS PERFORMED. ON (B)(6) 2022, THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT IN RESPONSE TO THE EVENT, HEPARIN DRIPS WERE STARTED AND RECOMMENDED SURGICAL REMOVAL OF THROMBUS AND LEFT ATRIAL APPENDAGE LIGATION BY CARDIO-THORACIC SURGERY. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR FURTHER MANAGEMENT. ON (B)(6) 2022, CARDIAC CATHETERIZATION WAS PERFORMED WHICH REVEALED LEFT MAIN CORONARY ARTERY WAS NORMAL, LEFT ANTERIOR DESCENDING ARTERY IN MID-VESSEL LESION THERE WAS AN 80% STENOSIS, 1ST DIAGONAL (OSTIAL LESION) WAS 90% STENOSIS, LEFT CIRCUMFLEX (MID-VESSEL LESION) WAS 30% STENOSIS, 3RD OBTUSE MARGINAL (MID-VESSEL LESION) WAS 90% STENOSIS, RIGHT CORONARY ARTERY (PROXIMAL VESSEL LESION) WAS 50% STENOSIS, RIGHT POSTERIOR DESCENDING (PROXIMAL VESSEL LESION) WAS 80% STENOSIS AND RIGHT CORONARY ARTERY POSTEROLATERAL EXTENSION LESION WAS 90% STENOSIS. ON (B)(6) 2022, MULTI-VESSEL CORONARY DISEASE WAS NOTED AND IN RESPONSE CORONARY ARTERY BYPASS SURGERY (CABG) WAS SCHEDULED. ON (B)(6) 2022, CHEST X-RAY REVEALED PERSISTENT CARDIAC ENLARGEMENT, NO ACUTE PULMONARY FINDINGS, LEFT CHEST PACEMAKER WAS AGAIN NOTED WITH LEADS IN THE RIGHT ATRIUM AND RIGHT VENTRICLE AND WATCHMAN DEVICE WAS NOTED. ON (B)(6) 2022, AS PLANNED AND RECOMMENDED STERNOTOMY WAS PERFORMED AND SINGLE AORTIC CORONARY BYPASS GRAFTING WITH LEFT INTERNAL MAMMARY TO THE APICAL LEFT ANTERIOR DESCENDING AORTA ALONG WITH THAT WATCHMAN WAS ALSO REMOVED OUT OF THE LEFT ATRIAL APPENDAGE WITHOUT ANY SIGNIFICANT DAMAGE TO THE APPENDAGE AND ALL THE INTERATRIAL CLOT WAS CAREFULLY REMOVED AND LIGATION OF LEFT ATRIAL APPENDAGE WERE PERFORMED. POST PROCEDURE, CHEST TUBES WERE PLACED TO COLLECT DRAIN AND LATER STERNOTOMY WAS CLOSED, THE PATIENT WAS HEMODYNAMICALLY STABLE AND SHIFTED TO RECOVERY ROOM. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED. ON (B)(6) 2022, THE PATIENT CONDITION WAS STABLE AND RECOMMENDED ASPIRIN. ON THE SAME DAY, CHEST X-RAY REVEALED ENDOTRACHEAL TUBE WAS REMOVED, LINES/TUBES WERE REMAINED STABLE AND UNCHANGED OF POSITION. MARGINALLY IMPROVED AERATION IN BOTH LUNGS SINCE FROM PRIOR EXAMINATION, NO PNEUMOTHORAX AND CARDIAC SIZE WAS STABLE. ON (B)(6) 2022, CHEST TUBE WAS REMOVED, AND LATER CHEST X-RAY WAS PERFORMED WHICH REVEALED RIGHT INTERNAL JUGULAR LINE REMAINED IN PLACE. BILATERAL CHEST TUBES, STABLE CARDIAC ENLARGEMENT AND LEFT-SIDED CHEST TUBE HAS BEEN REMOVED. TRACE RESIDUAL LEFT APICAL PNEUMOTHORAX, APPROXIMATELY 2 MM. IMPROVED LUNG AERATION, SUBSEGMENTAL ATELECTASIS IN THE RIGHT PERIHILAR REGION AND BILATERAL LUNG BASES WERE NOTED. ON (B)(6) 2022, CHEST X-RAY REVEALED SUPPORTING LINES/TUBES ARE IN STABLE, UNCHANGED POSITION. STABLE SMALL RIGHT APICAL PNEUMOTHORAX. NO NEW OR PROGRESSIVE AIRSPACE DISEASE OR CONSOLIDATION, OVERALL CHEST WAS STABLE AND CARDIAC SIZE WAS STABLE. ON (B)(6) 2022, THE PATIENT COMPLAINED OF BACK PAIN AND ALSO THE CHEST TUBE WAS NOT REMOVED, DRAIN WAS COLLECTED AND RECOMMENDED TO TAKE OPIATES AS NEEDED TO CONTROL PAIN. ON (B)(6) 2022, ULTRASOUND OF THE CHEST REVEALED GRAYSCALE AND COLOR DOPPLER SONOGRAPHY OF THE CHEST WAS PERFORMED. THERE WAS A SMALL AMOUNT OF COMPLEX-APPEARING NON-DRAINABLE MATERIAL WITHIN THE LATERAL LEFT PLEURAL SPACE NEAR THE SCAPULA WHICH LIKELY REPRESENTS A SMALL AMOUNT OF POST OPERATIVE HEMOTHORAX AND THERE WAS NO SIGNIFICANT PLEURAL FLUID ON THE RIGHT. ANEMIA WAS NOTED DUE TO ACUTE POST OPERATIVE BLOOD LOSS ALSO THROMBOCYTOPENIA AND HYPONATREMIA WERE NOTED. ON (B)(6) 2022, THE PATIENT COMPLAINED OF CHEST PAIN AND RECOMMENDED TO CONTINUE PULMONARY HYGIENE AND ENSURE ADEQUATE PAIN CONTROL TO ALLOW FOR DEEP BREATHING AND COUGH. ON (B)(6) 2022, THE PATIENT NOTED WITH ORTHOSTATIC SLIGHT INCREASE IN CREATININE WITH DIURESIS AND IN RESPONSE LASIX WAS DISCONTINUED AND IV BOLUS WAS STARTED. THE PATIENT WAS KEPT FOR OBSERVATION WAS RECHECKED FOR ORTHOSTATIC CONDITION. ON THE SAME DAY, CHEST X-RAY REVEALED LEFT CHEST TUBE APPEARED REMOVED WITH CONTINUED MILD INTERSTITIAL PROMINENCE IN THE LUNGS WITH IMPROVED AERATION. PERSISTENT SMALL LEFT BASILAR PLEURAL EFFUSION WITH MILD UNDERLYING CONSOLIDATION OR COLLAPSE, NO DEFINITE PNEUMOTHORAX, STABLE CARDIOMEGALY AND PREVIOUS STERNOTOMY WITH LEFT-SIDED PACER. ON (B)(6) 2022, PATIENT HAD 2 EPISODES OF ORTHOSTATIC HYPOTENSION AND AMBULATION WAS RECOMMENDED. ON THE SAME DAY, CHEST X-RAY REVEALED PERSISTENT LEFT BASILAR EFFUSION WITH MILD CONSOLIDATION OR COLLAPSE, IMPROVED MILD INTERSTITIAL PROMINENCE ELSEWHERE IN THE LUNGS, STABLE CARDIOMEGALY WITH PREVIOUS STERNOTOMY, LEFT-SIDED PACER REMAINED AND NO SIGNS FOR PNEUMOTHORAX. ON (B)(6) 2022, THE PATIENT WAS WEAK AND UNABLE TO STAND FOR A LONG AND COMPLIANT OF BACK PAIN. ON THE SAME DAY, CHEST X-RAY REVEALED SMALL LEFT EFFUSION WITH ASSOCIATED ATELECTASIS UNCHANGED. NO NEW AIRSPACE OPACITY, NO PNEUMOTHORAX AND STABLE CARDIOMEGALY. ON (B)(6) 2022, PATIENT WAS DISCHARGED WITH STABLE CONDITION ON ASPIRIN AND RECOMMENDED ELIQUIS FOR 1 MONTH AND ALSO RECOMMENDED SHORT TERM REHABILITATION FOR FURTHER CARE.
THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY ON 30 JUNE 2021 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN (81MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE(LAA) CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2021 WITH SUCCESSFUL PLACEMENT OF A 31 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26.0 MM. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND WARFARIN. ON (B)(6) 2022, 121 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA-IMAGING AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 60% AND COMPLETE SEAL WITH A PEDUNCULATED, NON-MOBILE WITH MAXIMUM AREA OF 7.2 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE AND ALSO PRESENCE OF NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 7.2 CM2, 3.8X3.1CM OVERLYING THE WATCHMAN DEVICE IN THE LEFT ATRIUM. HOWEVER, THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT. IN RESPONSE TO THE EVENT, CARDIOTHORACIC SURGERY WAS PERFORMED. ON 07FEB2022, THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT IN RESPONSE TO THE EVENT, HEPARIN DRIPS WERE STARTED AND RECOMMENDED SURGICAL REMOVAL OF THROMBUS AND LEFT ATRIAL APPENDAGE LIGATION BY CARDIO-THORACIC SURGERY. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR FURTHER MANAGEMENT. ON (B)(6) 2022, CARDIAC CATHETERIZATION WAS PERFORMED WHICH REVEALED LEFT MAIN CORONARY ARTERY WAS NORMAL, LEFT ANTERIOR DESCENDING ARTERY IN MID-VESSEL LESION THERE WAS AN 80% STENOSIS, 1ST DIAGONAL (OSTIAL LESION) WAS 90% STENOSIS, LEFT CIRCUMFLEX (MID-VESSEL LESION) WAS 30% STENOSIS, 3RD OBTUSE MARGINAL (MID-VESSEL LESION) WAS 90% STENOSIS, RIGHT CORONARY ARTERY (PROXIMAL VESSEL LESION) WAS 50% STENOSIS, RIGHT POSTERIOR DESCENDING (PROXIMAL VESSEL LESION) WAS 80% STENOSIS AND RIGHT CORONARY ARTERY POSTEROLATERAL EXTENSION LESION WAS 90% STENOSIS. ON (B)(6) 2022, MULTI-VESSEL CORONARY DISEASE WAS NOTED AND IN RESPONSE CORONARY ARTERY BYPASS SURGERY (CABG) WAS SCHEDULED. ON (B)(6) 2022, CHEST X-RAY REVEALED PERSISTENT CARDIAC ENLARGEMENT, NO ACUTE PULMONARY FINDINGS, LEFT CHEST PACEMAKER WAS AGAIN NOTED WITH LEADS IN THE RIGHT ATRIUM AND RIGHT VENTRICLE AND WATCHMAN DEVICE WAS NOTED. ON (B)(6) 2022, AS PLANNED AND RECOMMENDED STERNOTOMY WAS PERFORMED AND SINGLE AORTIC CORONARY BYPASS GRAFTING WITH LEFT INTERNAL MAMMARY TO THE APICAL LEFT ANTERIOR DESCENDING AORTA ALONG WITH THAT WATCHMAN WAS ALSO REMOVED OUT OF THE LEFT ATRIAL APPENDAGE WITHOUT ANY SIGNIFICANT DAMAGE TO THE APPENDAGE AND ALL THE INTERATRIAL CLOT WAS CAREFULLY REMOVED AND LIGATION OF LEFT ATRIAL APPENDAGE WERE PERFORMED. POST PROCEDURE, CHEST TUBES WERE PLACED TO COLLECT DRAIN AND LATER STERNOTOMY WAS CLOSED, THE PATIENT WAS HEMODYNAMICALLY STABLE AND SHIFTED TO RECOVERY ROOM. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED. ON (B)(6) 2022, THE PATIENT CONDITION WAS STABLE AND RECOMMENDED ASPIRIN. ON THE SAME DAY, CHEST X-RAY REVEALED ENDOTRACHEAL TUBE WAS REMOVED, LINES/TUBES WERE REMAINED STABLE AND UNCHANGED OF POSITION. MARGINALLY IMPROVED AERATION IN BOTH LUNGS SINCE FROM PRIOR EXAMINATION, NO PNEUMOTHORAX AND CARDIAC SIZE WAS STABLE. ON (B)(6) 2022, CHEST TUBE WAS REMOVED, AND LATER CHEST X-RAY WAS PERFORMED WHICH REVEALED RIGHT INTERNAL JUGULAR LINE REMAINED IN PLACE. BILATERAL CHEST TUBES, STABLE CARDIAC ENLARGEMENT AND LEFT-SIDED CHEST TUBE HAS BEEN REMOVED. TRACE RESIDUAL LEFT APICAL PNEUMOTHORAX, APPROXIMATELY 2 MM. IMPROVED LUNG AERATION, SUBSEGMENTAL ATELECTASIS IN THE RIGHT PERIHILAR REGION AND BILATERAL LUNG BASES WERE NOTED. ON 10FEB2022, CHEST X-RAY REVEALED SUPPORTING LINES/TUBES ARE IN STABLE, UNCHANGED POSITION. STABLE SMALL RIGHT APICAL PNEUMOTHORAX. NO NEW OR PROGRESSIVE AIRSPACE DISEASE OR CONSOLIDATION, OVERALL CHEST WAS STABLE AND CARDIAC SIZE WAS STABLE. ON (B)(6) 2022, THE PATIENT COMPLAINED OF BACK PAIN AND ALSO THE CHEST TUBE WAS NOT REMOVED, DRAIN WAS COLLECTED AND RECOMMENDED TO TAKE OPIATES AS NEEDED TO CONTROL PAIN. ON (B)(6) 2022, ULTRASOUND OF THE CHEST REVEALED GRAYSCALE AND COLOR DOPPLER SONOGRAPHY OF THE CHEST WAS PERFORMED. THERE WAS A SMALL AMOUNT OF COMPLEX-APPEARING NON-DRAINABLE MATERIAL WITHIN THE LATERAL LEFT PLEURAL SPACE NEAR THE SCAPULA WHICH LIKELY REPRESENTS A SMALL AMOUNT OF POST OPERATIVE HEMOTHORAX AND THERE WAS NO SIGNIFICANT PLEURAL FLUID ON THE RIGHT. ANEMIA WAS NOTED DUE TO ACUTE POST OPERATIVE BLOOD LOSS ALSO THROMBOCYTOPENIA AND HYPONATREMIA WERE NOTED. ON (B)(6) 2022, THE PATIENT COMPLAINED OF CHEST PAIN AND RECOMMENDED TO CONTINUE PULMONARY HYGIENE AND ENSURE ADEQUATE PAIN CONTROL TO ALLOW FOR DEEP BREATHING AND COUGH. ON (B)(6) 2022, THE THE PATIENT NOTED WITH ORTHOSTATIC SLIGHT INCREASE IN CREATININE WITH DIURESIS AND IN RESPONSE LASIX WAS DISCONTINUED AND IV BOLUS WAS STARTED. THE PATIENT WAS KEPT FOR OBSERVATION WAS RECHECKED FOR ORTHOSTATIC CONDITION. ON THE SAME DAY, CHEST X-RAY REVEALED LEFT CHEST TUBE APPEARED REMOVED WITH CONTINUED MILD INTERSTITIAL PROMINENCE IN THE LUNGS WITH IMPROVED AERATION. PERSISTENT SMALL LEFT BASILAR PLEURAL EFFUSION WITH MILD UNDERLYING CONSOLIDATION OR COLLAPSE, NO DEFINITE PNEUMOTHORAX, STABLE CARDIOMEGALY AND PREVIOUS STERNOTOMY WITH LEFT-SIDED PACER. ON (B)(6) 2022, PATIENT HAD 2 EPISODES OF ORTHOSTATIC HYPOTENSION AND AMBULATION WAS RECOMMENDED. ON THE SAME DAY, CHEST X-RAY REVEALED PERSISTENT LEFT BASILAR EFFUSION WITH MILD CONSOLIDATION OR COLLAPSE, IMPROVED MILD INTERSTITIAL PROMINENCE ELSEWHERE IN THE LUNGS, STABLE CARDIOMEGALY WITH PREVIOUS STERNOTOMY, LEFT-SIDED PACER REMAINED AND NO SIGNS FOR PNEUMOTHORAX. ON (B)(6) 2022, THE PATIENT WAS WEAK AND UNABLE TO STAND FOR A LONG AND COMPLIANT OF BACK PAIN. ON THE SAME DAY, CHEST X-RAY REVEALED SMALL LEFT EFFUSION WITH ASSOCIATED ATELECTASIS UNCHANGED. NO NEW AIRSPACE OPACITY, NO PNEUMOTHORAX AND STABLE CARDIOMEGALY. ON (B)(6) 2022, PATIENT WAS DISCHARGED WITH STABLE CONDITION ON ASPIRIN AND RECOMMENDED ELIQUIS FOR 1 MONTH AND ALSO RECOMMENDED SHORT TERM REHABILITATION FOR FURTHER CARE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021, THE PATIENT WAS DISCHARGED ON ASPIRIN, APIXABAN AND WARFARIN. ON (B)(6) 2022, THE THROMBOSIS WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2022, THE PATIENT DEVELOPED DIZZINESS. ONE DAY LATER, THE SUBJECT COMPLIANT OF CHEST PAIN AND WAS RECOMMENDED TO CONTINUE PULMONARY HYGIENE AND ENSURE ADEQUATE PAIN CONTROL TO ALLOW FOR DEEP BREATHING AND COUGH. ON (B)(6) 2022, THE PATIENT WAS WEAK AND UNABLE TO STAND FOR A LONG, COMPLIANT OF BACK PAIN AND WAS NOT ABLE TO TRANSFERRED INDEPENDENTLY SO DISCHARGE WAS DELAYED TO (B)(6) 2022.
THE PATIENT WAS ENROLLED IN THE CHAMPION-ATRIAL FIBRILLATION STUDY ON (B)(6) 2021 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN (81MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2021 WITH SUCCESSFUL PLACEMENT OF A 31 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26.0 MM. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND WARFARIN. ON (B)(6) 2022, 121 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA-IMAGING AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 60% AND COMPLETE SEAL WITH A PEDUNCULATED, NON-MOBILE WITH MAXIMUM AREA OF 7.2 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE AND ALSO PRESENCE OF NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 7.2 CM2, 3.8X3.1CM OVERLYING THE WATCHMAN DEVICE IN THE LEFT ATRIUM. HOWEVER, THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT. IN RESPONSE TO THE EVENT, CARDIOTHORACIC SURGERY WAS PERFORMED. ON (B)(6) 2022, THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT IN RESPONSE TO THE EVENT, HEPARIN DRIPS WERE STARTED AND RECOMMENDED SURGICAL REMOVAL OF THROMBUS AND LEFT ATRIAL APPENDAGE LIGATION BY CARDIO-THORACIC SURGERY. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR FURTHER MANAGEMENT. ON (B)(6) 2022, CARDIAC CATHETERIZATION WAS PERFORMED WHICH REVEALED LEFT MAIN CORONARY ARTERY WAS NORMAL, LEFT ANTERIOR DESCENDING ARTERY IN MID-VESSEL LESION THERE WAS AN 80% STENOSIS, 1ST DIAGONAL (OSTIAL LESION) WAS 90% STENOSIS, LEFT CIRCUMFLEX (MID-VESSEL LESION) WAS 30% STENOSIS, 3RD OBTUSE MARGINAL (MID-VESSEL LESION) WAS 90% STENOSIS, RIGHT CORONARY ARTERY (PROXIMAL VESSEL LESION) WAS 50% STENOSIS, RIGHT POSTERIOR DESCENDING (PROXIMAL VESSEL LESION) WAS 80% STENOSIS AND RIGHT CORONARY ARTERY POSTEROLATERAL EXTENSION LESION WAS 90% STENOSIS. ON (B)(6) 2022, MULTI-VESSEL CORONARY DISEASE WAS NOTED AND IN RESPONSE CORONARY ARTERY BYPASS SURGERY (CABG) WAS SCHEDULED. ON (B)(6) 2022, CHEST X-RAY REVEALED PERSISTENT CARDIAC ENLARGEMENT, NO ACUTE PULMONARY FINDINGS, LEFT CHEST PACEMAKER WAS AGAIN NOTED WITH LEADS IN THE RIGHT ATRIUM AND RIGHT VENTRICLE AND WATCHMAN DEVICE WAS NOTED. ON (B)(6) 2022, AS PLANNED AND RECOMMENDED STERNOTOMY WAS PERFORMED AND SINGLE AORTIC CORONARY BYPASS GRAFTING WITH LEFT INTERNAL MAMMARY TO THE APICAL LEFT ANTERIOR DESCENDING AORTA ALONG WITH THAT WATCHMAN WAS ALSO REMOVED OUT OF THE LEFT ATRIAL APPENDAGE WITHOUT ANY SIGNIFICANT DAMAGE TO THE APPENDAGE AND ALL THE INTERATRIAL CLOT WAS CAREFULLY REMOVED AND LIGATION OF LEFT ATRIAL APPENDAGE WERE PERFORMED. POST PROCEDURE, CHEST TUBES WERE PLACED TO COLLECT DRAIN AND LATER STERNOTOMY WAS CLOSED, THE PATIENT WAS HEMODYNAMICALLY STABLE AND SHIFTED TO RECOVERY ROOM. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED. ON (B)(6) 2022, THE PATIENT CONDITION WAS STABLE AND RECOMMENDED ASPIRIN. ON THE SAME DAY, CHEST X-RAY REVEALED ENDOTRACHEAL TUBE WAS REMOVED, LINES/TUBES WERE REMAINED STABLE AND UNCHANGED OF POSITION. MARGINALLY IMPROVED AERATION IN BOTH LUNGS SINCE FROM PRIOR EXAMINATION, NO PNEUMOTHORAX AND CARDIAC SIZE WAS STABLE. ON (B)(6) 2022, CHEST TUBE WAS REMOVED, AND LATER CHEST X-RAY WAS PERFORMED WHICH REVEALED RIGHT INTERNAL JUGULAR LINE REMAINED IN PLACE. BILATERAL CHEST TUBES, STABLE CARDIAC ENLARGEMENT AND LEFT-SIDED CHEST TUBE HAS BEEN REMOVED. TRACE RESIDUAL LEFT APICAL PNEUMOTHORAX, APPROXIMATELY 2 MM. IMPROVED LUNG AERATION, SUBSEGMENTAL ATELECTASIS IN THE RIGHT PERIHILAR REGION AND BILATERAL LUNG BASES WERE NOTED. ON (B)(6) 2022, CHEST X-RAY REVEALED SUPPORTING LINES/TUBES ARE IN STABLE, UNCHANGED POSITION. STABLE SMALL RIGHT APICAL PNEUMOTHORAX. NO NEW OR PROGRESSIVE AIRSPACE DISEASE OR CONSOLIDATION, OVERALL CHEST WAS STABLE AND CARDIAC SIZE WAS STABLE. ON (B)(6) 2022, THE PATIENT COMPLAINED OF BACK PAIN AND ALSO THE CHEST TUBE WAS NOT REMOVED, DRAIN WAS COLLECTED AND RECOMMENDED TO TAKE OPIATES AS NEEDED TO CONTROL PAIN. ON (B)(6) 2022, ULTRASOUND OF THE CHEST REVEALED GRAYSCALE AND COLOR DOPPLER SONOGRAPHY OF THE CHEST WAS PERFORMED. THERE WAS A SMALL AMOUNT OF COMPLEX-APPEARING NON-DRAINABLE MATERIAL WITHIN THE LATERAL LEFT PLEURAL SPACE NEAR THE SCAPULA WHICH LIKELY REPRESENTS A SMALL AMOUNT OF POST OPERATIVE HEMOTHORAX AND THERE WAS NO SIGNIFICANT PLEURAL FLUID ON THE RIGHT. ANEMIA WAS NOTED DUE TO ACUTE POST OPERATIVE BLOOD LOSS ALSO THROMBOCYTOPENIA AND HYPONATREMIA WERE NOTED. ON (B)(6) 2022, THE PATIENT COMPLAINED OF CHEST PAIN AND RECOMMENDED TO CONTINUE PULMONARY HYGIENE AND ENSURE ADEQUATE PAIN CONTROL TO ALLOW FOR DEEP BREATHING AND COUGH. ON (B)(6) 2022, THE PATIENT NOTED WITH ORTHOSTATIC SLIGHT INCREASE IN CREATININE WITH DIURESIS AND IN RESPONSE LASIX WAS DISCONTINUED AND IV BOLUS WAS STARTED. THE PATIENT WAS KEPT FOR OBSERVATION WAS RECHECKED FOR ORTHOSTATIC CONDITION. ON THE SAME DAY, CHEST X-RAY REVEALED LEFT CHEST TUBE APPEARED REMOVED WITH CONTINUED MILD INTERSTITIAL PROMINENCE IN THE LUNGS WITH IMPROVED AERATION. PERSISTENT SMALL LEFT BASILAR PLEURAL EFFUSION WITH MILD UNDERLYING CONSOLIDATION OR COLLAPSE, NO DEFINITE PNEUMOTHORAX, STABLE CARDIOMEGALY AND PREVIOUS STERNOTOMY WITH LEFT-SIDED PACER. ON (B)(6) 2022, PATIENT HAD 2 EPISODES OF ORTHOSTATIC HYPOTENSION AND AMBULATION WAS RECOMMENDED. ON THE SAME DAY, CHEST X-RAY REVEALED PERSISTENT LEFT BASILAR EFFUSION WITH MILD CONSOLIDATION OR COLLAPSE, IMPROVED MILD INTERSTITIAL PROMINENCE ELSEWHERE IN THE LUNGS, STABLE CARDIOMEGALY WITH PREVIOUS STERNOTOMY, LEFT-SIDED PACER REMAINED AND NO SIGNS FOR PNEUMOTHORAX. ON (B)(6) 2022, THE PATIENT WAS WEAK AND UNABLE TO STAND FOR A LONG AND COMPLIANT OF BACK PAIN. ON THE SAME DAY, CHEST X-RAY REVEALED SMALL LEFT EFFUSION WITH ASSOCIATED ATELECTASIS UNCHANGED. NO NEW AIRSPACE OPACITY, NO PNEUMOTHORAX AND STABLE CARDIOMEGALY. ON (B)(6) 2022, PATIENT WAS DISCHARGED WITH STABLE CONDITION ON ASPIRIN AND RECOMMENDED ELIQUIS FOR 1 MONTH AND ALSO RECOMMENDED SHORT TERM REHABILITATION FOR FURTHER CARE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021, THE PATIENT WAS DISCHARGED ON ASPIRIN, APIXABAN AND WARFARIN. ON (B)(6) 2022, THE THROMBOSIS WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2022, THE PATIENT DEVELOPED DIZZINESS. ONE DAY LATER, THE SUBJECT COMPLIANT OF CHEST PAIN AND WAS RECOMMENDED TO CONTINUE PULMONARY HYGIENE AND ENSURE ADEQUATE PAIN CONTROL TO ALLOW FOR DEEP BREATHING AND COUGH. ON (B)(6) 2022, THE PATIENT WAS WEAK AND UNABLE TO STAND FOR A LONG, COMPLIANT OF BACK PAIN AND WAS NOT ABLE TO TRANSFERRED INDEPENDENTLY SO DISCHARGE WAS DELAYED TO (B)(6) 2022. IT WAS FURTHER REPORTED THAT ON (B)(6) 2022, THE MEDICAL DECISION WAS MADE TO HOSPITALIZE THE PATIENT FOR FURTHER EVALUATION AND TREATMENT. THE PATIENT WAS STARTED ON HEPARIN DRIPS AND CARDIOTHORACIC SURGEON WAS CONSULTED WHO RECOMMENDED PATIENT TO UNDERGO CARDIAC CATHETERIZATION, FOLLOWED BY SURGICAL REMOVAL OF THROMBUS, AND LEFT ATRIAL APPENDAGE LIGATION. ON (B)(6) 2022, HEPARIN DRIPS WERE DISCONTINUED, AND PATIENT WAS TRANSFERRED TO OPERATING ROOM FOR THE PLANNED STERNOTOMY PROCEDURE. A HUGE LEFT ATRIAL CLOT WHICH ORIGINATED FROM THE WATCHMAN AND FILLED THE ENTIRE LEFT SIDE OF THE ATRIUM WAS REMOVED AND ALSO THE WATCHMAN DEVICE WAS PEELED OUT OF THE LEFT ATRIAL APPENDAGE WITHOUT ANY SIGNIFICANT DAMAGE TO THE APPENDAGE. LATER LIGATION OF LEFT ATRIAL APPENDAGE WAS PERFORMED. ADDITIONALLY, A SINGLE AORTIC CORONARY BYPASS GRAFT WITH LEFT INTERNAL MAMMARY TO THE APICAL LEFT ANTERIOR DESCENDING ARTERY WAS PERFORMED. POST PROCEDURE, CHEST TUBES WERE PLACED TO COLLECT DRAIN AND LATER STERNOTOMY WAS CLOSED, WITH 8 STAINLESS STEEL WIRES AFTER ANTIBIOTIC IRRIGATION. THE PATIENT WAS HEMODYNAMICALLY STABLE AND WAS SHIFTED TO RECOVERY ROOM. ON (B)(6) 2022, THE PATIENT WAS STARTED ON ASPIRIN (81MG/ DAY). ON THE SAME DAY, THE PATIENT WAS NOTED WITH ANEMIA DUE TO ACUTE POST OPERATIVE BLOOD LOSS, LEUKOCYTOSIS, AND THROMBOCYTOPENIA HOWEVER AS THE PATIENT WAS STABLE, AND IMPROVING, NO ACTION WAS TAKEN, AND PATIENT WAS CONTINUED TO BE MONITORED. ON (B)(6) 2022, PATIENT WAS NOTED WITH HYPONATREMIA, IN RESPONSE TO WHICH FLUID INTAKE WAS RESTRICTED AND PATIENT WAS MONITORED. THE PATIENT HAD 2 EPISODES ORTHOSTATIC HYPOTENSION DUE TO WHICH AMLODIPINE AND LASIX WERE DISCONTINUED AND IV BOLUS WAS STARTED. PATIENT WAS KEPT UNDER OBSERVATION TO RECHECK THE ORTHOSTATIC CONDITION. ON (B)(6) 2022, THE PATIENT WAS STARTED ON APIXABAN (10MG/ DAY). THE PATIENT WAS WEAK AND UNABLE TO STAND FOR A LONG OR TRANSFER INDEPENDENTLY SO DISCHARGE WAS DELAYED. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON ASPIRIN (81MG) AND APIXABAN (10MG) AND WAS RECOMMENDED SHORT TERM REHABILITATION FOR FURTHER CARE.
THE PATIENT WAS ENROLLED IN THE CHAMPION-ATRIAL FIBRILLATION STUDY ON 30 JUNE 2021 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN (81MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE(LAA) CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2021 WITH SUCCESSFUL PLACEMENT OF A 31 MM WATCHMAN FLX DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26.0 MM. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND WARFARIN. ON (B)(6) 2022, 121 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA-IMAGING AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 60% AND COMPLETE SEAL WITH A PEDUNCULATED, NON-MOBILE WITH MAXIMUM AREA OF 7.2 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE AND ALSO PRESENCE OF NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 7.2 CM2, 3.8X3.1CM OVERLYING THE WATCHMAN DEVICE IN THE LEFT ATRIUM. HOWEVER, THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT. IN RESPONSE TO THE EVENT, CARDIOTHORACIC SURGERY WAS PERFORMED. ON 07FEB2022, THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT IN RESPONSE TO THE EVENT, HEPARIN DRIPS WERE STARTED AND RECOMMENDED SURGICAL REMOVAL OF THROMBUS AND LEFT ATRIAL APPENDAGE LIGATION BY CARDIO-THORACIC SURGERY. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR FURTHER MANAGEMENT. ON (B)(6) 2022, CARDIAC CATHETERIZATION WAS PERFORMED WHICH REVEALED LEFT MAIN CORONARY ARTERY WAS NORMAL, LEFT ANTERIOR DESCENDING ARTERY IN MID-VESSEL LESION THERE WAS AN 80% STENOSIS, 1ST DIAGONAL (OSTIAL LESION) WAS 90% STENOSIS, LEFT CIRCUMFLEX (MID-VESSEL LESION) WAS 30% STENOSIS, 3RD OBTUSE MARGINAL (MID-VESSEL LESION) WAS 90% STENOSIS, RIGHT CORONARY ARTERY (PROXIMAL VESSEL LESION) WAS 50% STENOSIS, RIGHT POSTERIOR DESCENDING (PROXIMAL VESSEL LESION) WAS 80% STENOSIS AND RIGHT CORONARY ARTERY POSTEROLATERAL EXTENSION LESION WAS 90% STENOSIS. ON (B)(6) 2022, MULTI-VESSEL CORONARY DISEASE WAS NOTED AND IN RESPONSE CORONARY ARTERY BYPASS SURGERY (CABG) WAS SCHEDULED. ON (B)(6) 2022, CHEST X-RAY REVEALED PERSISTENT CARDIAC ENLARGEMENT, NO ACUTE PULMONARY FINDINGS, LEFT CHEST PACEMAKER WAS AGAIN NOTED WITH LEADS IN THE RIGHT ATRIUM AND RIGHT VENTRICLE AND WATCHMAN DEVICE WAS NOTED. ON (B)(6) 2022, AS PLANNED AND RECOMMENDED STERNOTOMY WAS PERFORMED AND SINGLE AORTIC CORONARY BYPASS GRAFTING WITH LEFT INTERNAL MAMMARY TO THE APICAL LEFT ANTERIOR DESCENDING AORTA ALONG WITH THAT WATCHMAN WAS ALSO REMOVED OUT OF THE LEFT ATRIAL APPENDAGE WITHOUT ANY SIGNIFICANT DAMAGE TO THE APPENDAGE AND ALL THE INTERATRIAL CLOT WAS CAREFULLY REMOVED AND LIGATION OF LEFT ATRIAL APPENDAGE WERE PERFORMED. POST PROCEDURE, CHEST TUBES WERE PLACED TO COLLECT DRAIN AND LATER STERNOTOMY WAS CLOSED, THE PATIENT WAS HEMODYNAMICALLY STABLE AND SHIFTED TO RECOVERY ROOM. ON THE SAME DAY, THE EVENT WAS CONSIDERED RESOLVED. ON (B)(6) 2022, THE PATIENT CONDITION WAS STABLE AND RECOMMENDED ASPIRIN. ON THE SAME DAY, CHEST X-RAY REVEALED ENDOTRACHEAL TUBE WAS REMOVED, LINES/TUBES WERE REMAINED STABLE AND UNCHANGED OF POSITION. MARGINALLY IMPROVED AERATION IN BOTH LUNGS SINCE FROM PRIOR EXAMINATION, NO PNEUMOTHORAX AND CARDIAC SIZE WAS STABLE. ON (B)(6) 2022, CHEST TUBE WAS REMOVED, AND LATER CHEST X-RAY WAS PERFORMED WHICH REVEALED RIGHT INTERNAL JUGULAR LINE REMAINED IN PLACE. BILATERAL CHEST TUBES, STABLE CARDIAC ENLARGEMENT AND LEFT-SIDED CHEST TUBE HAS BEEN REMOVED. TRACE RESIDUAL LEFT APICAL PNEUMOTHORAX, APPROXIMATELY 2 MM. IMPROVED LUNG AERATION, SUBSEGMENTAL ATELECTASIS IN THE RIGHT PERIHILAR REGION AND BILATERAL LUNG BASES WERE NOTED. ON (B)(6) 2022, CHEST X-RAY REVEALED SUPPORTING LINES/TUBES ARE IN STABLE, UNCHANGED POSITION. STABLE SMALL RIGHT APICAL PNEUMOTHORAX. NO NEW OR PROGRESSIVE AIRSPACE DISEASE OR CONSOLIDATION, OVERALL CHEST WAS STABLE AND CARDIAC SIZE WAS STABLE. ON (B)(6) 2022, THE PATIENT COMPLAINED OF BACK PAIN AND ALSO THE CHEST TUBE WAS NOT REMOVED, DRAIN WAS COLLECTED AND RECOMMENDED TO TAKE OPIATES AS NEEDED TO CONTROL PAIN. ON (B)(6) 2022, ULTRASOUND OF THE CHEST REVEALED GRAYSCALE AND COLOR DOPPLER SONOGRAPHY OF THE CHEST WAS PERFORMED. THERE WAS A SMALL AMOUNT OF COMPLEX-APPEARING NON-DRAINABLE MATERIAL WITHIN THE LATERAL LEFT PLEURAL SPACE NEAR THE SCAPULA WHICH LIKELY REPRESENTS A SMALL AMOUNT OF POST OPERATIVE HEMOTHORAX AND THERE WAS NO SIGNIFICANT PLEURAL FLUID ON THE RIGHT. ANEMIA WAS NOTED DUE TO ACUTE POST OPERATIVE BLOOD LOSS ALSO THROMBOCYTOPENIA AND HYPONATREMIA WERE NOTED. ON (B)(6) 2022, THE PATIENT COMPLAINED OF CHEST PAIN AND RECOMMENDED TO CONTINUE PULMONARY HYGIENE AND ENSURE ADEQUATE PAIN CONTROL TO ALLOW FOR DEEP BREATHING AND COUGH. ON (B)(6) 2022, THE PATIENT NOTED WITH ORTHOSTATIC SLIGHT INCREASE IN CREATININE WITH DIURESIS AND IN RESPONSE LASIX WAS DISCONTINUED AND IV BOLUS WAS STARTED. THE PATIENT WAS KEPT FOR OBSERVATION WAS RECHECKED FOR ORTHOSTATIC CONDITION. ON THE SAME DAY, CHEST X-RAY REVEALED LEFT CHEST TUBE APPEARED REMOVED WITH CONTINUED MILD INTERSTITIAL PROMINENCE IN THE LUNGS WITH IMPROVED AERATION. PERSISTENT SMALL LEFT BASILAR PLEURAL EFFUSION WITH MILD UNDERLYING CONSOLIDATION OR COLLAPSE, NO DEFINITE PNEUMOTHORAX, STABLE CARDIOMEGALY AND PREVIOUS STERNOTOMY WITH LEFT-SIDED PACER. ON (B)(6) 2022, PATIENT HAD 2 EPISODES OF ORTHOSTATIC HYPOTENSION AND AMBULATION WAS RECOMMENDED. ON THE SAME DAY, CHEST X-RAY REVEALED PERSISTENT LEFT BASILAR EFFUSION WITH MILD CONSOLIDATION OR COLLAPSE, IMPROVED MILD INTERSTITIAL PROMINENCE ELSEWHERE IN THE LUNGS, STABLE CARDIOMEGALY WITH PREVIOUS STERNOTOMY, LEFT-SIDED PACER REMAINED AND NO SIGNS FOR PNEUMOTHORAX. ON (B)(6) 2022, THE PATIENT WAS WEAK AND UNABLE TO STAND FOR A LONG AND COMPLIANT OF BACK PAIN. ON THE SAME DAY, CHEST X-RAY REVEALED SMALL LEFT EFFUSION WITH ASSOCIATED ATELECTASIS UNCHANGED. NO NEW AIRSPACE OPACITY, NO PNEUMOTHORAX AND STABLE CARDIOMEGALY. ON (B)(6) 2022, PATIENT WAS DISCHARGED WITH STABLE CONDITION ON ASPIRIN AND RECOMMENDED ELIQUIS FOR 1 MONTH AND ALSO RECOMMENDED SHORT TERM REHABILITATION FOR FURTHER CARE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021, THE PATIENT WAS DISCHARGED ON ASPIRIN, APIXABAN AND WARFARIN. ON (B)(6) 2022, THE THROMBOSIS WAS CONSIDERED TO BE RESOLVED. ON (B)(6) 2022, THE PATIENT DEVELOPED DIZZINESS. ONE DAY LATER, THE SUBJECT COMPLIANT OF CHEST PAIN AND WAS RECOMMENDED TO CONTINUE PULMONARY HYGIENE AND ENSURE ADEQUATE PAIN CONTROL TO ALLOW FOR DEEP BREATHING AND COUGH. ON (B)(6) 2022, THE PATIENT WAS WEAK AND UNABLE TO STAND FOR A LONG, COMPLIANT OF BACK PAIN AND WAS NOT ABLE TO TRANSFERRED INDEPENDENTLY SO DISCHARGE WAS DELAYED TO (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1330225 | WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | 10390 | 0027474954 | 08714729860518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention |