BEUDAMED
    FDA Adverse Event Summary report: N

    LARIAT SUTURE DELIVERY SYSTEM

    MDR report key: 3212851 · Received July 8, 2013

    Report

    Report Number
    MW5030798
    Date Received
    July 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 21, 2013
    Manufacturer
    SENTROHEART INC
    Product Code
    GAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT IS A (B)(6) WITH A HISTORY OF FIBRILLATION. SHE HAD TO STOP TAKING HER COUMADIN RELATED TO GI BLEEDING. PT WAS REFERRED FOR THE LIGATION PROCEDURE TO ALLEVIATE THE RISK OF CLOT FROM ATRIAL FIBRILLATION AND HER INABILITY TO TAKE CHRONIC ANTICOAGULATION. PT UNDERWENT LARIAT (LEFT ATRIAL APPENDAGE LIGATION DEVICE) PROCEDURE ON (B)(6) 2013. MFR OF THE LARIAT DEVICE IS SENTROHEART. PROCEDURE WAS UNEVENTFUL AS PER GUIDELINES OF SENTROHEART AS COMPANY REPS WERE PRESENT FOR THE PROCEDURE. AT THE CONCLUSION OF THE PROCEDURE THE PT DEVELOPED LOW BLOOD PRESSURE. TRANS-ESOPHAGEAL ECHOCARDIOGRAM CONFIRMED THE PRESENCE OF A LARGE PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. ATTEMPTS WERE MADE TO DRAIN BLOOD VIA PIGTAIL CATHETER INSERTION. THE CARDIAC DRAIN FAILED TO STABILIZE THE PT. THE PT'S HEMODYNAMICS CONTINUED TO WORSEN AND SHE NEEDED AN EMERGENT STERNOTOMY TO SAVE HER LIFE. THE SURGEON FOUND THE PT HAD 2 LOBES TO THEIR LEFT ATRIAL APPENDAGE. THE LARIAT SUTURE WAS ON THE MORE CAUDAL LOBE AND THERE WAS A LACERATION IN THE OTHER MORE SUPERIOR LOBE JUST OPPOSITE THE LARIAT. THE MAJORITY OF THE LEFT ATRIAL APPENDAGE WAS INTACT WITH A SIGNIFICANT CUL-DE-SAC. THIS LACERATION WAS SUCCESSFULLY CLOSED BY THE SURGEON. THE PT SURVIVED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSP AFTER AN 8 DAY POST-SURGICAL HOSPITALIZATION STAY. WE BELIEVE THAT THE COMPLICATIONS THAT AROSE WITH THIS PROCEDURE ARE DIRECTLY A RESULT OF DEVICE FAILURE/MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311809 LARIAT SUTURE DELIVERY SYSTEM LARIAT SUTURE DELIVERY SYSTEM GAT SENTROHEART INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L LARIAT SUTURE DELIVERY DEVICE