BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 19713636 · Received July 10, 2024

    Report

    Report Number
    2135147-2024-03332
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    May 27, 2024
    Report Date
    July 25, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013503
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF CHEST PAIN, SHORTNESS OF BREATH, PERICARDIAL EFFUSION LEAD TO CARDIAC TAMPONADE ON NINETY DAY NINETY DAYS POST PROCEDURE WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT STATUS WAS STABLE. 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 CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 27 FEBRUARY 2024, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED IN A PATIENT. PATIENT WAS DISCHARGED, HAD ONE MONTH FOLLOW-UP AND REPORTED FEELING FINE. NO 45 DAY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS OBTAINED. ON (B)(6) 2024, 90 DAYS POST PROCEDURE, THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH CHEST PAIN AND SHORTNESS OF BREATH, AND 1.2 LITERS OF DARK RED BLOOD WAS DRAINED FROM HEART VIA PERICARDIOCENTESIS. THE PATIENT WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366957 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8835806 00811806013503

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention