Description of Event or Problem · 0
THE PATIENT WAS ENROLLED IN THE HEAL-LAA STUDY ON (B)(6) 2023 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT DEVICE DID NOT SEAL. ON (B)(6) 2023, THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WITH SUCCESSFUL PLACEMENT OF A 40MM WATCHMAN FLX PRO DEVICE WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 31MM. THE PATIENT WAS DISCHARGED WITH ASPIRIN AND APIXABAN THE SAME DAY. ON (B)(6) 2023, 40 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH EXERTIONAL SHORTNESS OF BREATH AND WEAKNESS. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND APIXABAN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT AND WAS DIAGNOSED WITH CONGESTIVE HEART FAILURE. INTRAVENOUS (IV) LASIX WAS GIVEN TO TREAT THE EVENT. ON (B)(6) 2023, FORTY-TWO (42) DAYS POST PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING ASSESSMENT WAS PERFORMED WHICH REVEALED THE DEVICE POSITION IN THE LAA WAS AT OSTIUM (PLANE OF MAXIMUM DIAMETER IS WITHIN 2MM OF THE DESIRED OSTIAL PLANE), WITH A RESIDUAL JET SIZE NOTED AROUND THE DEVICE OF 3MM. NO INTERVENTIONS WERE PERFORMED TO CLOSE THE LEAK AND THERE WAS NO PERICARDIAL EFFUSION OR THROMBUS NOTED. ON (B)(6) 2023, THE PATIENT MEDICATION WAS CHANGED FROM APIXABAN TO CLOPIDOGREL. ON (B)(6) 2024, CLOPIDOGREL WAS STOPPED AND ON (B)(6) 2024, ASPIRIN WAS DISCONTINUED. ON (B)(6) 2024, 54 DAYS POST INDEX PROCEDURE, THE PATIENT DIED FROM COMPLICATIONS RELATED TO CONGESTIVE HEART FAILURE. THE PATIENT CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE AND WAS UNRELATED TO THE WATCHMAN DEVICE(S) OR PROCEDURE.