BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET DELIVERY SYSTEM

    MDR report key: 11385475 · Received February 26, 2021

    Report

    Report Number
    2135147-2021-00057
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    February 5, 2021
    Report Date
    February 26, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF THROMBUS FORMATION IN A PATIENT WITH A MEDICAL HISTORY INCLUDING GENETIC THROMBOPHILIA WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2021, A 22MM AMPLATZER AMULET LEFT ATRIAL APPRENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER AMULET DELIVERY SYSTEM IN A PATIENT WITH A PAST MEDICAL HISTORY OF GENETIC THROMBOPHILIA. DURING THE PROCEDURE, A THROMBUS DEVELOPED ON THE SHEATH IN THE LEFT ATRIUM. THE OCCLUDER WAS RETRACTED AND THE THROMBUS WAS ASPIRATED. ULTIMATELY, A DEVICE WAS NOT IMPLANTED. THE USER ATTRIBUTED THE THROMBUS FORMATION TO THE DELIVERY SYSTEM. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. IT WAS REPORTED THAT ASSESSMENT OF THE DEVICE PLACEMENT AND STABILITY WAS PROLONGED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284647 AMPLATZER AMULET DELIVERY SYSTEM MLV ABBOTT MEDICAL DS-TV45X45-12F-080 7105139

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R