BEUDAMED
    FDA Adverse Event Death Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 3289486 · Received August 9, 2013

    Report

    Report Number
    3005802238-2013-00008
    Event Type
    Death
    Date Received
    August 9, 2013
    Date of Event
    July 12, 2013
    Report Date
    August 9, 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 PROCEDURE TO CAPTURE AND DEPLOY THE SUTURE ON THE APPENDAGE WAS UNREMARKABLE AND COMPLETE CLOSURE OF THE APPENDAGE WAS NOTED. THE LARIAT WAS REMOVED AND, AS THE SURECUT WAS BEING LOADED TO CUT THE REMNANT SUTURE TAIL, THE DOCTOR OBSERVED THAT THE SUTURE PULLED OUT OF THE BODY AND A SIGNIFICANT EFFUSION DEVELOPED. A SURGEON WAS ON STANDBY IN THE ROOM AND IMMEDIATELY ATTEMPTED TO LOCATE AND STOP THE BLEEDING VIA A PERICARDIAL WINDOW. WHEN THAT WAS UNSUCCESSFUL, A MEDIAN STERNOTOMY WAS PERFORMED AND THE SURGEON WAS ABLE TO SUCCESSFULLY CLOSE THE TISSUE AT THE BASE OF THE APPENDAGE AND STOP THE BLEEDING. THE PATIENT WAS REPORTED STABLE FOLLOWING THE PROCEDURE. WE WERE NOTIFIED THAT THE PATIENT EXPIRED 9 DAYS LATER. THE ROOT CAUSE IS UNKNOWN. THE LAA TISSUE IS KNOWN TO BE VERY FRIABLE. THERE IS NO EVIDENCE TO SUGGEST A DEVICE MALFUNCTION AS THE EFFUSION DEVELOPED FOLLOWING A SUCCESSFUL LIGATION OF THE LAA. A REVIEW OF MANUFACTURING RECORDS CONFIRMED THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE LARIAT WAS BEING USED TO LIGATE THE LEFT ATRIAL APPENDAGE IN A HYBRID OPERATING ROOM. A SIGNIFICANT EFFUSION DEVELOPED SHORTLY AFTER LARIAT WAS REMOVED FROM THE PATIENT REQUIRING IMMEDIATE SURGERY. THE SURGEON WAS ABLE TO STOP THE BLEEDING AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. WE WERE SUBSEQUENTLY NOTIFIED THAT THE PATIENT EXPIRED 9 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381231 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA 70712029

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R