BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19730706 · Received July 12, 2024

    Report

    Report Number
    2124215-2024-43000
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    May 21, 2024
    Report Date
    July 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GILBERT, P., & HASHMI, S. (2024). LEFT CIRCUMFLEX FISTULA AFTER WATCHMAN IMPLANTATION: A CASE REPORT OF LEFT ATRIAL APPENDAGE CLOSURE COMPLICATION. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS, 102147.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE: IT WAS REPORTED THAT THERE WAS A FISTULA. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. 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. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT CAME IN FOR A TEN (10) WEEK FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING PROCEDURE. THE IMAGING SHOWED APPROPRIATE PLACEMENT OF DEVICE WITH 2-MM TRIVIAL PDL AND NO EVIDENCE OF THROMBUS. THE PATIENTS MITRAL VALVE REGURGITATION HAD PROGRESSED FROM MODERATE TO SEVERE. APIXABAN WAS DISCONTINUED THREE (3) MONTHS POSTOPERATIVELY AND THE PATIENT REMAINED ON ASPIRIN AND CLOPIDOGREL. PREPROCEDURAL LEFT HEART CATHETERIZATION FOR EVALUATION OF A NON-BSC CLIP PLACEMENT FOR SEVERE MITRAL VALVE REGURGITATION PERFORMED SIX (6) WEEKS AFTER FOLLOW-UP TEE NOTED ACCUMULATION OF CONTRAST WITHIN THE LAA. SUBSEQUENT LEFT HEART CATHETERIZATION DEMONSTRATED PASSAGE OF CONTRAST BETWEEN THE LEFT CIRCUMFLEX ARTERY AND THE LAA CONSISTENT WITH A FISTULA. THE PATIENT WAS MANAGED CONSERVATIVELY AND THEIR CLOPIDOGREL WAS DISCONTINUED. THEIR POSTOPERATIVE COURSE WAS UNCOMPLICATED WITH NO ISSUES UPON FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236569 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other