BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 20441138 · Received October 14, 2024

    Report

    Report Number
    2124215-2024-62420
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    July 23, 2024
    Report Date
    October 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 07/23/2024 AS THE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 23 JULY 2024. CITATION: ZOU Q, JIANG C, LIN P, YU Y, LI J, ZHAO F, HU H AND SUN S (2024) MANAGEMENT OF COMPLICATIONS ASSOCIATED WITH PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE WITH OR WITHOUT ABLATION: EXPERIENCE FROM 512 CASES OVER A 4 YEAR PERIOD. FRONT. CARDIOVASC. MED. 11:1388024. DOI: 10.3389/FCVM.2024.1388024

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE IT WAS REPORTED THAT A POTENTIAL SYSTEMIC EMBOLIC EVENT OCCURRED. A 76-YEAR-OLD FEMALE PATIENT CONSULTED FOR ISCHEMIC STROKE TREATMENT WHERE SHE WAS DIAGNOSED WITH ATRIAL FIBRILLATION (AF) FOLLOWING A COMPREHENSIVE EVALUATION. THE PATIENT HAD A HAS-BLED SCORE OF 6 (HYPERTENSION, ABNORMAL LIVER FUNCTION, STROKE, LABILE INR, ELDERLY, LONG-TERM USE OF NSAIDS) AND ALSO HAD COGNITIVE IMPAIRMENT. AFTER RULING OUT ANY CONTRAINDICATIONS, A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS PERFORMED AS A STROKE PREVENTATIVE MEASURE. POST FEMORAL VEIN PUNCTURE, 5,500 UNITS OF HEPARIN WERE ADMINISTERED, AND THE ACTIVATED CLOTTING TIME (ACT) WAS MONITORED AT 320 SECONDS AFTER 5 MINUTES. SUBSEQUENT SEPTAL PUNCTURE AND LAA DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) REVEALED A WINDSOCK MORPHOLOGY. A 21MM WATCHMAN CLOSURE DEVICE WAS SUCCESSFULLY PLACED WITHIN THE LAA, ACHIEVING A COMPRESSION RATIO OF 15%-20%. UPON DISCHARGE, THE PATIENT COMMENCED ANTIPLATELET THERAPY WITH CLOPIDOGREL (75 MG DAILY) AND ASPIRIN (100 MG DAILY). FOLLOW-UP EVALUATIONS SHOWED THE OCCLUDER WAS WELL-POSITIONED WITH NO PERI DEVICE LEAK (PDL), AND THE PATIENT EXPERIENCED NO ISCHEMIC STROKE, TRANSIENT ISCHEMIC ATTACK (TIA), OR HEMORRHAGIC COMPLICATIONS. HOWEVER, 6 MONTHS POST-PROCEDURE, THE PATIENT PRESENTED WITH LEG PAIN AFTER WALKING. LOWER EXTREMITY VASCULAR ULTRASOUND REVEALED OCCLUSION IN THE LEFT ANTERIOR TIBIAL AND FOOT ARTERIES, WITH ELEVATED D-DIMER LEVELS. THESE RAISED CONCERNS OF A POTENTIAL SYSTEMIC EMBOLIC EVENT FOLLOWING LAAC. INVESTIGATION INTO THE PATIENT'S MEDICATION ADHERENCE REVEALED SHE HAD BEEN TAKING ONLY ASPIRIN POSTOPERATIVELY. WE RECOMMENDED ADDING RIVAROXABAN (20 MG DAILY) TO HER REGIMEN FOR ENHANCED ANTICOAGULATION AND ANTIPLATELET EFFECT. THIS ADJUSTED TREATMENT APPROACH LED TO NO FURTHER ADVERSE EVENTS IN SUBSEQUENT FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810090 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other