BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 16274009 · Received January 31, 2023

    Report

    Report Number
    2135147-2023-00341
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    January 3, 2023
    Report Date
    April 12, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013497
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    NAD1 - BRAND NAME: UPDATED TO AMPLATZER AMULET; D2A COMMON DEVICE NAME: UPDATED TO CARDIAC PLUG; D2B - PROCODE: UPDATED TO NGV; D4 - CATALOG #: UPDATED TO 9-ACP2-010-025; D4 - LOT #: UPDATED TO 8499671; D4 - EXPIRATION DATE: UPDATED TO 4/30/2027; D4 - UDI #: UPDATED TO (B)(4).

    Additional Manufacturer Narrative · 0

    AN EVENT OF PERICARDIAL EFFUSION AND ARRHYTHMIA WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. FIELD NOTED THAT PATIENTS HAD MEDICAL HISTORY OF PAF, HTN, OSA, BRADYCARDIA WHICH MAY HAVE CONTRIBUTED THE REPORTED EVENT. 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED INTO A PATIENT USING A 14F AMPLATZER STEERABLE DELIVERY SHEATH. ON (B)(6) 2022, A SMALL PERICARDIAL EFFUSION WAS DISCOVERED BY TRANSTHORACIC ECHOCARDIOGRAM (TTE). NO TREATMENT WAS DONE. ON (B)(6) 2023, THE PATIENT DEVELOPED BRADYCARDIA AND A PERMANENT PACEMAKER WAS IMPLANTED. ON (B)(6) 2023, THE PREVIOUSLY NOTED PERICARDIAL EFFUSION HAD GROWN, AND WAS TREATED WITH PERICARDIOCENTESIS; 800ML OF FLUID WAS DRAINED. THE PATIENT IS REPORTED TO BE STABLE AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871792 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL ASDS-14F-075 8499671 00811806013497

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention