BEUDAMED
    FDA Adverse Event Death Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 3124298 · Received May 14, 2013

    Report

    Report Number
    3005802238-2013-00005
    Event Type
    Death
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 14, 2013
    Manufacturer
    SENTREHEART, INC.
    Product Code
    GAT
    PMA / PMN Number
    K090385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE SENTREHEART REPRESENTATIVE WHO ATTENDED THE CASE. THE LIGATION PROCEDURE ITSELF WAS UNREMARKABLE AND WAS COMPLETED WITH NO UNUSUAL CIRCUMSTANCES. THE RESISTANCE ENCOUNTERED WHEN TRYING TO REMOVE THE LARIAT WAS INITIALLY THOUGHT TO BE INTERFERENCE FROM THE GUIDEWIRE. AFTER SEVERAL ATTEMPTS TO REPOSITION THE LARIAT AND GUIDEWIRE, THE DOCTOR WAS UNABLE TO RESOLVE THE RESISTANCE AND CONTINUED TO PULL. WHEN THE DOCTOR REMOVED THE LARIAT, HE COULD SEE THAT THE LAA HAD BECOME DISLODGED AND SENT THE PT FOR EMERGENCY SURGERY. UPON EXAMINATION OF THE LARIAT AFTER THE CASE, THE DOCTOR OBSERVED THAT HE FAILED TO REMOVE THE SUTURE RELEASE TAB. THIS RESULTED IN THE APPLICATION OF DIRECT TENSILE FORCE TO THE SUTURE LOOP CAUSING IT TO TEAR THE LAA FROM THE LEFT ATRIUM WALL. STEP 20 OF THE IFU CAUTIONS THE USER: "IF RESISTANCE IS FELT DURING REMOVAL OF THE LARIAT DEVICE, DO NOT ATTEMPT TO FORCE REMOVAL AND STOP TO IDENTIFY POTENTIAL CAUSES. VERIFY THE SUTURE RELEASE TAB IS REMOVED, DELIVERY SNARE IS OPEN, SUTURE IS FULLY DEPLOYED AND DEVICE IS FREE OF ANATOMICAL CONSTRAINTS OR INSTRUMENT INTERFERENCE." THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. A REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPMENT. THE ROOT CAUSE APPEARS TO BE USER ERROR IN FAILING TO REMOVE THE SUTURE RELEASE TAB PRIOR TO WITHDRAWAL OF THE LARIAT FROM THE PT.

    Description of Event or Problem · 1

    THE LARIAT WAS BEING USED TO LIGATE THE LEFT ATRIAL APPENDAGE. THE PROCEDURE WAS COMPLETED AND A SUCCESSFUL LIGATION WAS NOTED. THE DOCTOR ENCOUNTERED RESISTANCE WHEN ATTEMPTING TO WITHDRAW THE LARIAT AT THE END OF THE PROCEDURE. THE DOCTOR WAS UNABLE TO DETERMINE THE CAUSE OF THE RESISTANCE AND CONTINUED TO PULL IN AN ATTEMPT TO REMOVE THE DEVICE FROM THE PT. WHEN THE DEVICE CAME OUT OF THE PT, THE SUTURE LOOP, ALONG WITH LAA TISSUE, CAME WITH IT. AN EFFUSION QUICKLY DEVELOPED AND THE PT WAS IMMEDIATELY SENT FOR EMERGENCY SURGERY. THE PT WAS PLACED ON BYPASS AND THE WALL OF THE LEFT ATRIUM WAS REPAIRED BY THE SURGEON AT THE LOCATION WHERE THE LAA OSTIUM HAD TORN OFF. DURING A FOLLOW UP CALL WITH THE DOCTOR, HE REPORTED THAT THE PT HAD SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213155 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART, INC. NA 71212075

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| R