BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6886642 · Received September 22, 2017

    Report

    Report Number
    2134265-2017-09445
    Event Type
    Injury
    Date Received
    September 22, 2017
    Report Date
    August 30, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: SAWAN N, ET AL. "ACCIDENTAL FINDING OF A THROMBUS FORMATION ON A LEFT ATRIAL APPENDAGE OCCLUDER DEVICE DURING LONG-TERM FOLLOW-UP", EUROPACE 2016: 18(SUPPLEMENT 1) P.I8. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THROMBUS OCCURRED. THE PATIENT HAD BEEN ADMITTED WITH RECURRENT SYMPTOMATIC COMMON TYPE ATRIAL FLUTTER. IN (B)(6) 2014 A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A33MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. PERIPROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED COMPLETE SEALING OF THE LAA. THE PATIENT WAS TREATED WITH CLOPIDOGREL AND ASA (ASPIRIN) FOR SIX WEEKS. TEE ELEVEN MONTHS AFTER IMPLANTATION SHOWED COMPLETE SEALING OF THE LAA WITHOUT EVIDENCE OF LA THROMBUS. THEREFORE, DUAL ANTIPLATELET THERAPY (DAPT) WAS DISCONTINUED. TWENTY ONE MONTHS POST DEVICE-IMPLANTATION, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR DC CARDIOVERSION FOR SYMPTOMATIC COMMON TYPE ATRIAL FLUTTER. TEE WAS PERFORMED PRIOR TO DC CARDIOVERSION TO SEEK FOR LA THROMBI. THE LAA WAS COMPLETELY SEALED, BUT A SESSILE THROMBUS (5X10X15MM) LOCATED ON THE DEVICE WAS FOUND. CONSEQUENTLY, DC CARDIOVERSION WAS NOT PERFORMED. THE PATIENT WAS RESTARTED ON ORAL ANTICOAGULATION WITH A VITAMIN K ANTAGONIST FOR 6 WEEKS AND RATE CONTROL WITH VERAPAMIL WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665572 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WS33060

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other