BEUDAMED
    FDA Adverse Event Death Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 9378453 · Received November 26, 2019

    Report

    Report Number
    3005802238-2019-00002
    Event Type
    Death
    Date Received
    November 26, 2019
    Date of Event
    November 1, 2019
    Report Date
    November 26, 2019
    Manufacturer
    SENTREHEART, INC.
    Product Code
    GAT
    PMA / PMN Number
    K153096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CASE (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER OF THE LARIAT DEVICE WAS NOT REPORTED OR ABLE TO BE ASCERTAINED. THERE WERE NO PROCEDURE REPORTED DEVICE MALFUNCTIONS OR COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019 A MALE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE MANAGEMENT PROCEDURE VIA THE LARIAT DEVICE. THERE WERE NO COMPLICATIONS AND COMPLETE CLOSURE WAS OBTAINED. PATIENT WAS DISCHARGED HOME ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT SUFFERED A FALL, TEMPORARY UNCONSCIOUSNESS AND WAS TAKEN TO THE ER. PATIENT DEVELOPED VENTRICULAR FIBRILLATION (VF) AND WENT INTO CARDIAC ARREST. UPON RECOVERING FROM VF, ORGAN DAMAGE WAS NOTED. PATIENT WAS TRANSPORTED TO ANOTHER FACILITY WHERE HE EXPIRED ON (B)(6) 2019 AFTER SUPPORT WAS WITHDRAWN. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170227 LARIAT SUTURE DELIVERY DEVICE LARIAT SUTURE DELIVERY DEVICE GAT SENTREHEART, INC. 30-06

    Patients

    Seq Age Sex Outcome Treatment
    1 Death