BEUDAMED
    FDA Adverse Event Death Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 10292057 · Received July 17, 2020

    Report

    Report Number
    3005802238-2019-00003
    Event Type
    Death
    Date Received
    July 17, 2020
    Date of Event
    August 21, 2018
    Report Date
    July 17, 2020
    Manufacturer
    SENTREHEART, INC.
    Product Code
    GAT
    PMA / PMN Number
    K142241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER FOR THE DEVICE WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018 A (B)(6)-YEAR-OLD FEMALE PATIENT WITH A MEDICAL HISTORY OF PERSISTENT ATRIAL FIBRILLATION, HYPERTENSION, CORONARY ARTERY DISEASE, PACEMAKER, HYPOTENSION, AND CONGESTIVE HEART FAILURE CONSENTED TO PARTICIPATE IN THE AMAZE TRIAL (IDE#(B)(4)/PROTOCOL#(B)(4)) AND ON (B)(6) 2018 UNDERWENT THE INDEX PROCEDURE WITH THE LARIAT SUTURE DELIVERY DEVICE. PRE-PROCEDURE A TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED ABSENCE OF THROMBUS. DURING PROCEDURE PERICARDIAL AND TRANS-SEPTAL ACCESS ACHIEVED USING GENERAL ANESTHESIA AND PRE-TIED SUTURE WAS DEPLOYED AROUND THE LAA. THE SUTURE WAS TIGHTENED WITH PRE-SPECIFIED "TENSURE" FORCE. AT THAT POINT, AN ACUTE DECLINE IN BLOOD PRESSURE WAS NOTICED AND CARDIAC PERFORATION WAS SUSPECTED. TEE SHOWED PERICARDIAL EFFUSION AND TAMPONADE. CPR WAS PERFORMED INTERMITTENTLY; THE SUBJECT WAS PLACED ON CARDIOPULMONARY BYPASS. IT WAS NOTED BY THE SURGEON THAT THE EPICARDIAL LIGATURE HAD PERFORATED THROUGH THE BASE OF THE LEFT ATRIAL APPENDAGE RESULTING IN PATIENT MORTALITY. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION. EVENT WAS INDEPENDENTLY ADJUDICATED AND REPORTED TO FDA IN IDE#(B)(4) ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754960 LARIAT SUTURE DELIVERY DEVICE LARIAT SUTURE DELIVERY DEVICE GAT SENTREHEART, INC. 30-06 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death