BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 11408962 · Received March 4, 2021

    Report

    Report Number
    2134265-2021-02776
    Event Type
    Injury
    Date Received
    March 4, 2021
    Date of Event
    July 12, 2020
    Report Date
    March 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729838234
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 1

    (B)(6) STUDY IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. HEPARIN WAS GIVEN PRE TRANSSEPTAL PUNCTURE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 20.3 MM. AFTER THE IMPLANT THE SUBJECT WAS STARTED ON BOTH ASPIRIN AND CLOPIDOGREL. THE SUBJECT WAS DISCHARGED ON (B)(6) 2018. ON (B)(6) 2020, 725 DAYS POST INDEX PROCEDURE, THE SUBJECT HAD AN EPISODE OF TEMPORARY BLURRED OR DOUBLE VISION UPON WAKING UP.THE SYMPTOMS RESOLVED WITHIN AN HOUR WITHOUT ANY RESIDUAL DEFICITS. THE SUBJECT DENIED ANY FOCAL WEAKNESS, SPEECH PROBLEMS, SHORTNESS OF BREATH, RECENT ILLNESS, FALLS AND TRAUMA. AT THE TIME OF EVENT, THE SUBJECT WAS ON ASPIRIN. NEUROLOGICAL EXAMINATION REVEALED NO HEADACHE, DIZZINESS, NO PARESTHESIA, MEMORY PROBLEMS, SEIZURES OR SLEEP PROBLEMS. ON (B)(6) 2020, A CT HEAD WITHOUT CONTRAST WAS PERFORMED WHICH REVEALED NO ACUTE INTRACRANIAL FINDINGS, MILD TO MODERATE GLOBAL DIFFUSE ATROPHY, CHRONIC MICROVASCULAR ISCHEMIC DISEASE AND SMALL CHRONIC LACUNAR TYPE INFARCTIONS, CAUDATE NUCLEI BILATERALLY AND ANTERIOR RIGHT LENTIFORM NUCLEUS AND VASCULAR CALCIFICATION. THE DURATION OF FOCAL OR GLOBAL NEUROLOGICAL DEFICIT WAS LESS THAN 24 HOURS IN CASE OF IMAGING-DOCUMENTED NEW HEMORRHAGE OR INFARCT. THE EVENT WAS CLASSIFIED AS TRANSIENT ISCHEMIC ATTACK (TIA). THE SUSPECTED CAUSE OF THE EVENT WAS NOTED AS CAROTID STENOSIS OR MICRO-EMBOLI. THE SUBJECT WAS ADVISED TO TAKE ADDITIONAL ASPIRIN HOWEVER, THE SUBJECT CONFIRMED TAKING ONLY 81 MG ASPIRIN AS DEFINED BY PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305640 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0020597116 08714729838234

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other