BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 18935919 · Received March 19, 2024

    Report

    Report Number
    2135147-2024-01237
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 23, 2024
    Report Date
    April 30, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013503
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    AN EVENT OF PERICARDIAL EFFUSION WHICH LEAD TO CARDIAC TAMPONADE WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND 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. THERE WERE NO COMPLAINTS ASSOCIATED WITH ANY OTHER DEVICES FROM THE LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDERS WAS SELECTED FOR IMPLANT ON (B)(6) 2024. AT THE BEGINNING OF THE PROCEDURE IT WAS NOTED THAT 4000 UNITS OF HEPARIN WAS ADMINISTERED AND AFTER GAINING TRANSSEPTAL PUNCTURE, ANOTHER 3000 UNITS WAS ADMINISTERED. THE LEFT ATRIAL APPENDAGE (LAA) DIAMETER WAS MEASURED WITH ECHOCARDIOGRAM WITH THE LANDING ZONE AS 23MM AND THROUGH CT ANGIOGRAPHY AS24MM. THE ACT WAS MEASURED TWICE WITH AN INDEX ERROR OF 999. THE DEVICE WAS INSERTED INTO THE PATIENT. ONE PARTIAL RE-CAPTURE WAS NOTED. THE DEVICE WAS IMPLANTED. POST-IMPLANT A SMALL PERICARDIAL EFFUSION WAS NOTED. THE PERICARDIAL EFFUSION LED TO A CARDIAC TAMPONADE. THE ACT WAS MEASURED AGAIN WITH A SCORE OF 418. 3000 UNITS OF PROTAMINE WAS ADMINISTERED. TWO HOURS LATER A PERICARDIOCENTESIS WAS PERFORMED AND 450ML OF BLOOD WAS DRAINED. THE FOLLOWING DAY AN ADDITIONAL 250ML WAS DRAINED.

    Description of Event or Problem · 0

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755554 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8519083 00811806013503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R 14F AMPL TPRQ DS[DS-TV45X45-14F-080, LOT: 8731005]