BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER

    MDR report key: 13452987 · Received February 4, 2022

    Report

    Report Number
    2135147-2022-00030
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    December 14, 2021
    Report Date
    February 17, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013480
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF PERICARDIAL EFFUSION TWO WEEKS POST IMPLANT WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED 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 · 0

    IT WAS REPORTED THAT A 22MM AMPLATZER AMULET DEVICE WAS IMPLANTED ON (B)(6) 2021 WITH NO COMPLICATIONS. THE PATIENT WAS SEEN IN OFFICE ONE WEEK LATER AND NO EFFUSION WAS NOTED. APPROXIMATELY TWO WEEKS POST-IMPLANT, PATIENT COMPLAINED OF SHORTNESS OF BREATH. PATIENT WAS BROUGHT IN AND A PERICARDIAL EFFUSION WAS NOTED. PATIENT WAS SENT TO THE CARDIAC CATHETERIZATION LAB FOR PERICARDIOCENTESIS. APPROXIMATELY 200 ML¿S WAS REMOVED. PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY WITH NO FURTHER COMPLICATIONS. A COMPUTERIZED TOMOGRAPHY (CT) WAS ALSO PERFORMED WITH NO EVIDENCE OF CONTRAST PAST THE DEVICE. IT WAS NOTED THAT THE PATIENT HAD A BASE LINE OF ATRIAL FIBRILLATION WITH EPISODES OF RAPID ATRIAL FIBRILLATION FOLLOWED BY 4-6 SECOND PAUSES THAT MAY BE ASSOCIATED WITH THE PERICARDIAL EFFUSION. NO ADDITIONAL INFORMATION WAS PROVIDED. ((B)(6) 2022-NWT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562583 AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER TRANSCATHETER SEPTAL OCCLUDER NGV ABBOTT MEDICAL 9-ACP2-007-022 8120940 00811806013480

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H