BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATRICURE ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 7114818 · Received December 13, 2017

    Report

    Report Number
    3011706110-2017-00107
    Event Type
    Death
    Date Received
    December 13, 2017
    Report Date
    December 13, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K093679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE WERE NO PRODUCT MALFUNCTIONS OR PROCEDURE COMPLAINTS. THE DEVICE HISTORY REVIEW WAS COMPLETED AND THERE IS NOTHING IN THE DEVICE HISTORY REVIEW TO INDICATE THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT.

    Description of Event or Problem · 1

    ON 08/04/2017, THE DISTRIBUTOR WAS MADE AWARE OF A SURGICAL PROCEDURE FOR LAA CLOSURE WITH THE ATRICLIP ACH150/CABG/MVP WERE THE PATIENT WAS OFF PUMP, ON 11/16/2017, THE DISTRIBUTOR MADE THE MANUFACTURER AWARE OF THE EVENT. POST PROCEDURE, THE PATIENT HAD CATECHOLAMINE ADMINISTERED AND HIS EJECTION FRACTION WAS 20%. THE PATIENT DIED DURING THE INITIAL PROCEDURE TIMEFRAME OF CARDIAC FAILURE. THE SURGEON ATTRIBUTES THE CARDIAC FAILURE TO PATIENT¿S CONDITION AND STATED THAT THE DEATH HAD NO RELATIONSHIP TO THE CLIP AND THAT THERE WERE NO PROCEDURAL COMPLICATIONS. THE DATE OF THE INITIAL PROCEDURE AND DEATH WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893724 ATRICURE ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICURE ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP FZP ATRICURE, INC. ACH150 68863

    Patients

    Seq Age Sex Outcome Treatment
    1 Death