BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 13012162 · Received December 15, 2021

    Report

    Report Number
    2134265-2021-15763
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    August 1, 2020
    Report Date
    January 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ESTIMATED BASED ON IMPLANT DATE OF (B)(6) 2020 AND DEVICE RELATED THROMBUS DISCOVERY AT 45-DAY FOLLOW-UP LOT NUMBER.

    Additional Manufacturer Narrative · 0

    ESTIMATED BASED ON IMPLANT DATE OF (B)(6) 2021 AND DEVICE RELATED THROMBUS DISCOVERY AT 45-DAY FOLLOW-UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE RELATED THROMBUS (DRT) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. POST IMPLANT DRUG REGIMEN WAS ASPIRIN AND ORAL ANTICOAGULANT (OAC) MEDICATIONS. AT THE 45-DAY FOLLOW-UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A DRT ON THE THREADED INSERT TO THE LIMBUS. THE PATIENT CONTINUED OAC MEDICATIONS. AT THE 1-YEAR FOLLOW-UP, DRT WAS STILL PRESENT. THE PATIENT WAS INSTRUCTED TO CONTINUE OAC AND FOLLOW UP IN 1 YEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE RELATED THROMBUS (DRT) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. POST IMPLANT DRUG REGIMEN WAS ASPIRIN AND ORAL ANTICOAGULANT (OAC) MEDICATIONS. AT THE 45-DAY FOLLOW-UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A DRT ON THE THREADED INSERT TO THE LIMBUS. THE PATIENT CONTINUED OAC MEDICATIONS. AT THE 1-YEAR FOLLOW-UP, DRT WAS STILL PRESENT. THE PATIENT WAS INSTRUCTED TO CONTINUE OAC AND FOLLOW UP IN 1 YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908860 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0024492848

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other