BEUDAMED
    FDA Adverse Event Death Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 3369776 · Received September 18, 2013

    Report

    Report Number
    3005802238-2013-00009
    Event Type
    Death
    Date Received
    September 18, 2013
    Date of Event
    August 21, 2013
    Report Date
    September 18, 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 PRESENT DURING THE CASE. THE OPERATING CARDIAC SURGEON COMMENTED ON THE PATIENT'S EXTREMELY FRIABLE AND DELICATE TISSUE. IT WAS DIFFICULT TO RESOLVE THE BLEEDING BECAUSE THE TISSUE WOULD NOT HOLD THE SUTURES ANYWHERE. ALSO, IT WAS NOTED THAT SIGNIFICANT BLEEDING WAS EVIDENT AT THE GROIN SITE WHERE A FEMORAL CLOSURE DEVICE WAS USED TO CLOSE THE ARTERIAL ACCESS SITE. THE EXACT CAUSE OF THE BLEEDING IS UNKNOWN. ALTHOUGH THE DEVICE WAS NOT RETURNED FOR EVALUATION, THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. 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 ON A (B)(6) MALE. PRIOR TO LAA PROCEDURE, AN AORTIC VALVULOPLASTY WAS PERFORMED. DURING LAA LIGATION, IT WAS NOTED THAT ONLY A PORTION OF THE LAA WAS CAPTURED WITH THE LARIAT. THE PHYSICIAN CONTINUED WITH THE PROCEDURE AND AFTER TIGHTENING OF THE DEVICE AROUND THE LAA LOBE BLEEDING IMMEDIATELY OCCURRED. THE PATIENT WAS CONVERTED TO SURGERY TO RESOLVE THE BLEEDING BUT EXPIRED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470609 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| R