BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19661267 · Received July 2, 2024

    Report

    Report Number
    2124215-2024-40445
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    June 21, 2024
    Report Date
    January 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2 OUTCOMES ATTRIB TO ADV EVENT UPDATED TO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. B5 DESCRIBE EVENT OR PROBLEM: UPDATED WITH ADDITIONAL INFORMATION RECEIVED. H6: IMPACT CODE UPDATED FROM F26: NO HEALTH CONSEQUENCE OR IMPACT TO F2301: ADDITIONAL DEVICE REQUIRED.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE WATCHMAN FLX PRO CT STUDY ON (B)(6) 2024 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2024. A WATCHMAN ACCESS SYSTEM (WAS) AND A 31MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26.0 MM. THERE WERE NO COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. POST IMPLANT ECHO ASSESSMENT REVEALED COMPLETE SEAL AND NO EVIDENCE OF PERICARDIAL EFFUSION. THE PATIENT WAS DISCHARGED ON A MEDICATION REGIMEN OF ASPIRIN (75 MG /DAY). PROTOCOL REQUIRED 14-DAY FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) ASSESSMENT DATED (B)(6) 2024 REVEALED A RESIDUAL ATRIAL SEPTAL DEFECT (ASD) WITH SIZE OF 1 MM. HOWEVER, THERE WAS NO EVIDENCE OF PERI DEVICE LEAK AND PERICARDIAL EFFUSION. ON (B)(6) 2024, 44 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 45 DAY FOLLOW UP, AND TEE ASSESSMENT WAS PERFORMED WHICH REVEALED 1 PERI DEVICE LEAK OF 3 MM WIDTH OF COLOR JET, 90 DEGREES AND RESIDUAL ATRIAL SEPTAL DEFECT (ASD) WITH SIZE OF 3 MM WERE NOTED. THE COMPUTED TOMOGRAPHY (CT) ASSESSMENT REVEALED PERI DEVICE GAP OF 14 MM AT LONG AXIS AND 8 MM AT SHORT AXIS, PERI-DEVICE LEAK WAS NOTED AT INFERIOR AND POSTERIOR, 2, 3, 4 AND 5 O' CLOCK POSITION. THE PATIENT WAS ON A MEDICATION REGIME OF ASPIRIN (75 MG /DAY) AT THE TIME OF THE EVENT. THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION OR DEVICE-RELATED THROMBOSIS.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE WATCHMAN FLX PRO CT STUDY ON (B)(6) 2024 WITH PATIENT IDENTIFIER (B)(4). IT WAS REPORTED THAT DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2024. A WATCHMAN ACCESS SYSTEM (WAS) AND A 31MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26.0 MM. THERE WERE NO COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. POST IMPLANT ECHO ASSESSMENT REVEALED COMPLETE SEAL AND NO EVIDENCE OF PERICARDIAL EFFUSION. THE PATIENT WAS DISCHARGED ON A MEDICATION REGIMEN OF ASPIRIN (75 MG /DAY). PROTOCOL REQUIRED 14-DAY FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) ASSESSMENT DATED (B)(6) 2024 REVEALED A RESIDUAL ATRIAL SEPTAL DEFECT (ASD) WITH SIZE OF 1 MM. HOWEVER, THERE WAS NO EVIDENCE OF PERI DEVICE LEAK AND PERICARDIAL EFFUSION. ON (B)(6) 2024, 44 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 45 DAY FOLLOW UP, AND TEE ASSESSMENT WAS PERFORMED WHICH REVEALED 1 PERI DEVICE LEAK OF 3 MM WIDTH OF COLOR JET, 90 DEGREES AND RESIDUAL ATRIAL SEPTAL DEFECT (ASD) WITH SIZE OF 3 MM WERE NOTED. THE COMPUTED TOMOGRAPHY (CT) ASSESSMENT REVEALED PERI DEVICE GAP OF 14 MM AT LONG AXIS AND 8 MM AT SHORT AXIS, PERI-DEVICE LEAK WAS NOTED AT INFERIOR AND POSTERIOR, 2, 3, 4 AND 5 O' CLOCK POSITION. THE PATIENT WAS ON A MEDICATION REGIME OF ASPIRIN (75 MG /DAY) AT THE TIME OF THE EVENT. THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION OR DEVICE-RELATED THROMBOSIS. IT WAS FURTHER REPORTED THAT ON (B)(6) 2024, CLOSURE OF LEAK PROCEDURE WAS PERFORMED AND A 12MM NON-BOSTON SCIENTIFIC PLUG WAS IMPLANTED. FOLLOW UP CARDIAC CT WAS COMPLETED ON (B)(6) 2024 WHICH REVEALED MINIMAL RESIDUAL LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526197 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION CL6031 0030913726

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| O