BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 13318240 · Received January 21, 2022

    Report

    Report Number
    2134265-2022-00541
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    December 15, 2021
    Report Date
    April 1, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2021 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THE CLOSURE DEVICE DID NOT SEAL. PROCEDURE SUMMARY: THE PATIENT WAS ON ASPIRIN (81 MG) AND APIXABAN (10 MG) THERAPY PRIOR TO ENROLLMENT INTO THE STUDY. PRIOR TO INDEX PROCEDURE, ASPIRIN (81MG) AND APIXABAN (10 MG) WAS ADMINISTERED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 35 MM WATCHMAN FLX DEVICE WITH COMPLETE LEFT ATRIAL APPENDAGE(LAA) SEAL AND DEPLOYED DEVICE DIAMETER OF 24 MM. POST IMPLANT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED COMPLETE LAA SEAL WITH NO EVIDENCE OF THROMBUS AND PERICARDIAL EFFUSION. ONE DAY POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN (81MG) AND APIXABAN (10 MG). EVENT SUMMARY: ON (B)(6) 2021, 121 DAYS OF POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA-IMAGING, AND TEE ASSESSMENT REVEALED INCOMPLETE LAA SEAL WITH LARGEST RESIDUAL JET AROUND THE DEVICE OF 7 MM. HOWEVER, NO EVIDENCE OF THROMBUS AND PERICARDIAL EFFUSION. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN (81 MG).

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE CHAMPION-ATRIAL FIBRILLATION CLINICAL STUDY ON 02 AUG 2021 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THE CLOSURE DEVICE DID NOT SEAL. PROCEDURE SUMMARY: THE PATIENT WAS ON ASPIRIN (81 MG) AND APIXABAN (10 MG) THERAPY PRIOR TO ENROLLMENT INTO THE STUDY. PRIOR TO INDEX PROCEDURE, ASPIRIN (81MG) AND APIXABAN (10 MG) WAS ADMINISTERED. THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF A 35 MM WATCHMAN FLX DEVICE WITH COMPLETE LEFT ATRIAL APPENDAGE(LAA) SEAL AND DEPLOYED DEVICE DIAMETER OF 24 MM. POST IMPLANT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED COMPLETE LAA SEAL WITH NO EVIDENCE OF THROMBUS AND PERICARDIAL EFFUSION. ONE DAY POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN (81MG) AND APIXABAN (10 MG). EVENT SUMMARY: ON (B)(6) 2021, 121 DAYS OF POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA-IMAGING, AND TEE ASSESSMENT REVEALED INCOMPLETE LAA SEAL WITH LARGEST RESIDUAL JET AROUND THE DEVICE OF 7 MM. HOWEVER, NO EVIDENCE OF THROMBUS AND PERICARDIAL EFFUSION. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN (81 MG). IT WAS FURTHER REPORTED THAT PER THE SITE THE LARGEST RESIDUAL JET AROUND THE DEVICE HAS BEEN UPDATED FROM 7 MM TO 2 MM. AS THE JET SIZE IS BELOW 5 MM, THE EVENT HAS BEEN WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983347 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0027527357 08714729860525

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other