BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 17319753 · Received July 13, 2023

    Report

    Report Number
    2124215-2023-35069
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    January 1, 2021
    Report Date
    August 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: REMOVAL OF TACHYCARDIA CODING. B3: EVENT DATE ESTIMATED AS SPECIFIC DATE UNKNOWN, BUT REPORTED TO HAVE OCCURRED IN THE YEAR 2021. D6A: IMPLANT DATE ESTIMATED AS SPECIFIC DATE UNKNOWN BUT REPORTED TO HAVE BEEN IMPLANTED IN THE YEAR 2020. LITERATURE CITATION: BAOQUIONG LIU, MD, PHD; ALFONSO H. WALLER, MD (JULY 05, 2023). UNROOFED CORONARY SINUS AS POTENTIAL CAUSE OF ISCHEMIC STROKE FOLLOWING LEFT ATRIAL APPENDAGE CLOSURE. JACC: CASE REPORTS, VOLUME 17, 101892.

    Additional Manufacturer Narrative · 0

    EVENT DATE ESTIMATED AS SPECIFIC DATE UNKNOWN, BUT REPORTED TO HAVE OCCURRED IN THE YEAR 2021. IMPLANT DATE ESTIMATED AS SPECIFIC DATE UNKNOWN BUT REPORTED TO HAVE BEEN IMPLANTED IN THE YEAR 2020. LITERATURE CITATION: BAOQUIONG LIU, MD, PHD; ALFONSO H. WALLER, MD (JULY 05, 2023). UNROOFED CORONARY SINUS AS POTENTIAL CAUSE OF ISCHEMIC STROKE FOLLOWING LEFT ATRIAL APPENDAGE CLOSURE. JACC: CASE REPORTS, VOLUME 17, 101892.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE THAT CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A WATCHMAN CLOSURE DEVICE WAS IMPLANTED IN 2020. POST-IMPLANT, THE PATIENT CONTINUED APIXABAN FOR 45 DAYS, AND THEN WAS SWITCHED TO ANTIPLATELET THERAPY. IN 2021, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD DEMONSTRATED INTERVAL LEFT CEREBELLAR INFARCTION. AT THIS TIME, THE PATIENT WAS TAKING ASPIRIN 81MG DAILY. AT AN UNSPECIFIED TIME, THE PATIENT PRESENTED TO THE HOSPITAL WITH WORSENING HEADACHES, BLOOD PRESSURE OF 175/95, AND HEART RATE OF 95 BPM. PHYSICIAN EXAMINATION WAS UNREMARKABLE WITH NO NEUROLOGICAL DEFICITS. CT SCAN OF THE HEAD DEMONSTRATED INTERVAL LARGE RIGHT CEREBELLAR INFARCTION. THE PATIENT WAS REFERRED FOR A CARDIOLOGY CONSULTATION. LABORATORY STUDIES WERE UNREMARKABLE. ELECTROCARDIOGRAM DEMONSTRATED SINUS RHYTHM. TRANSTHORACIC ECHOCARDIOGRAM DEMONSTRATED A DILATED CORONARY SINUS. AGITATED SALINE INJECTED IN THE RIGHT UPPER EXTREMITY DID NOT DEMONSTRATE AN INTRACARDIAC SHUNT. HOWEVER, AGITATED SALINE FROM THE LEFT UPPER EXTREMITY DEMONSTRATED MICROBUBBLES APPEARING IN THE CORONARY SINUS, LEFT ATRIUM, AND LEFT VENTRICLE, CONFIRMING A PERSISTENT LEFT-SIDED SUPERIOR VENA CAVA WITH AN UNROOFED CORONARY SINUS. TRANSESOPHAGEAL ECHOCARDIOGRAM DEMONSTRATED THE PERSISTENT LEFT-SIDED SUPERIOR VENA CAVA DRAINING TO AN UNROOFED CORONARY SINUS. THE WATCHMAN CLOSURE DEVICE WAS WELL-SEATED AND THERE WAS NO LEAK. THE PATIENT WAS DISCHARGED ON APIXABAN 5MG TWICE DAILY FOR SUSPECTED PARADOXICAL EMBOLISM FROM THE LEFT UPPER EXTREMITY THROUGH THE PERSISTENT LEFT-SIDED SUPERIOR VENA CAVA AND UNROOFED CORONARY SINUS. RECURRENT ISCHEMIC STROKES, LUPUS (ON HYDROXYCHLOROQUINE), DIABETES MELLITUS, PERIPHERAL NEUROPATHY, CHRONIC KIDNEY DISEASE, CHRONIC SYSTOLIC HEART FAILURE (RECOVERED), PAROXYSMAL ATRIAL FIBRILLATION, RIGHT MIDDLE CEREBRAL ARTERY INFARCT (2019). LITERATURE CITATION: BAOQUIONG LIU, MD, PHD; ALFONSO H. WALLER, MD (JULY 05, 2023). UNROOFED CORONARY SINUS AS POTENTIAL CAUSE OF ISCHEMIC STROKE FOLLOWING LEFT ATRIAL APPENDAGE CLOSURE. JACC: CASE REPORTS, VOLUME 17, 101892.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE THAT CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A WATCHMAN CLOSURE DEVICE WAS IMPLANTED IN 2020. POST-IMPLANT, THE PATIENT CONTINUED APIXABAN FOR 45 DAYS, AND THEN WAS SWITCHED TO ANTIPLATELET THERAPY. IN 2021, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD DEMONSTRATED INTERVAL LEFT CEREBELLAR INFARCTION. AT THIS TIME, THE PATIENT WAS TAKING ASPIRIN 81MG DAILY. AT AN UNSPECIFIED TIME, THE PATIENT PRESENTED TO THE HOSPITAL WITH WORSENING HEADACHES, BLOOD PRESSURE OF 175/95, AND HEART RATE OF 95 BPM. PHYSICIAN EXAMINATION WAS UNREMARKABLE WITH NO NEUROLOGICAL DEFICITS. CT SCAN OF THE HEAD DEMONSTRATED INTERVAL LARGE RIGHT CEREBELLAR INFARCTION. THE PATIENT WAS REFERRED FOR A CARDIOLOGY CONSULTATION. LABORATORY STUDIES WERE UNREMARKABLE. ELECTROCARDIOGRAM DEMONSTRATED SINUS RHYTHM. TRANSTHORACIC ECHOCARDIOGRAM DEMONSTRATED A DILATED CORONARY SINUS. AGITATED SALINE INJECTED IN THE RIGHT UPPER EXTREMITY DID NOT DEMONSTRATE AN INTRACARDIAC SHUNT. HOWEVER, AGITATED SALINE FROM THE LEFT UPPER EXTREMITY DEMONSTRATED MICROBUBBLES APPEARING IN THE CORONARY SINUS, LEFT ATRIUM, AND LEFT VENTRICLE, CONFIRMING A PERSISTENT LEFT-SIDED SUPERIOR VENA CAVA WITH AN UNROOFED CORONARY SINUS. TRANSESOPHAGEAL ECHOCARDIOGRAM DEMONSTRATED THE PERSISTENT LEFT-SIDED SUPERIOR VENA CAVA DRAINING TO AN UNROOFED CORONARY SINUS. THE WATCHMAN CLOSURE DEVICE WAS WELL-SEATED AND THERE WAS NO LEAK. THE PATIENT WAS DISCHARGED ON APIXABAN 5MG TWICE DAILY FOR SUSPECTED PARADOXICAL EMBOLISM FROM THE LEFT UPPER EXTREMITY THROUGH THE PERSISTENT LEFT-SIDED SUPERIOR VENA CAVA AND UNROOFED CORONARY SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260346 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other