BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARIAT SUTURE DELIVERY DEVICE

    MDR report key: 3187228 · Received June 20, 2013

    Report

    Report Number
    3005802238-2013-00007
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 20, 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 INFO WAS PROVIDED BY THE SENTREHEART REP WHO ATTENDED THE CASE. THE PROCEDURE TO CAPTURE AND DEPLOY THE SUTURE ON THE APPENDAGE WAS UNREMARKABLE. UPON INITIAL TIGHTENING OF THE SUTURE FROM THE LARIAT, AN EFFUSION DEVELOPED. THE EFFUSION CONTINUED FOLLOWING SUBSEQUENT TIGHTENING WITH THE TENSURE. THE EFFUSION WAS UNABLE TO BE MANAGED WITH PERICARDIOCENTESIS AND, FOLLOWING A DROP IN BLOOD PRESSURE, THE PHYSICIAN DECIDED TO SEND THE PT TO SURGERY. THE SURGEON REPORTED FINDING A 3 MM LACERATION ON THE INFERIOR SURFACE OF THE LAA, PROXIMAL OF THE LARIAT SUTURE LOCATION. THE SURGEON NOTED THAT THE LAA WAS SURROUNDED WITH FATTY TISSUE AND THAT THE LACERATION WAS DESCRIBED AS A SMALL TEAR BETWEEN TRABECULATIONS. ADDITIONALLY, THE SURGEON NOTED THAT THE LAA TISSUE ITSELF WAS PARTICULARLY FRIABLE, MAKING IT DIFFICULT FOR THE SUTURE TO GET ANY PURCHASE ON THE TISSUE (HIS COMMENT WAS THE "TISSUE WAS LIKE TIRAMISU"). THE EXACT CAUSE OF THE LACERATION IS UNK. THE PT AS DISCHARGED 7 DAYS LATER. THE DEVICE WAS NOT RETURNED FOR EVAL AND THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. A REVIEW OF MFG 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. AN EFFUSION DEVELOPED SHORTLY AFTER THE SUTURE WAS TIGHTENED. PERICARDIOCENTESIS WAS THEN PERFORMED TO MANAGE THE EFFUSION, BUT THEN THE PT'S BLOOD PRESSURE DROPPED AND DOCTOR DECLINED TO SEND THE PT TO SURGERY WHERE THE LAA WAS SUTURED SURGICALLY. PT WAS REPORTED STABLE THE FOLLOWING DAY AND EXPECTED TO RECOVER NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281061 LARIAT SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA 70812043

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention