BEUDAMED
    FDA Adverse Event Death Summary report: N

    LARIAT+ SUTURE DELIVERY DEVICE

    MDR report key: 4751903 · Received May 4, 2015

    Report

    Report Number
    3005802238-2015-00004
    Event Type
    Death
    Date Received
    May 4, 2015
    Date of Event
    April 3, 2015
    Report Date
    April 30, 2015
    Manufacturer
    SENTREHEART INC.
    Product Code
    GAT
    PMA / PMN Number
    K142241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND THERE IS NO EVIDENCE TO SUGGEST THERE WAS A DEVICE MALFUNCTION. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THE DEVICE MET SPECIFICATION PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    (B)(6) FEMALE UNDERGOING LAA CLOSURE WITH THE LARIAT DEVICE PER REQUEST OF THEIR REFERRING PHYSICIAN. PATIENT'S MEDICAL HISTORY INCLUDES PERSISTENT AF, HIGH CHADS-VASC SCORE, CHRONIC RECURRENT GI BLEEDING FROM GASTRIC AVMS. THE LARIAT DEVICE WAS ADVANCED AND PLACED UNREMARKABLE AROUND THE LAA. THE SUTURE WAS DEPLOYED WITHOUT ISSUE; HOWEVER, REMOVAL OF THE DEVICE OFF THE LAA WAS DIFFICULT. SEVERAL ATTEMPTS WERE MADE UNTIL AN EFFUSION DEVELOPED AND THE PATIENT'S BLOOD PRESSURE BEGAN TO DECREASE. WITH THE EFFUSION MANAGED AND PATIENT STABILIZED, A LA ANGIOGRAM WAS DONE AND A DISSECTION AT THE LAA WAS NOTED. PHYSICIAN DECIDED TO SEND THE PATIENT TO SURGERY AT WHICH TIME THE PATIENT DE-STABILIZED AND CP WAS INITIATED. PER THE SURGEON, THE LAA WAS NOTED TO BE SUTURED OFF AT THE BASE BUT EVULSED FROM THE LA. THE SURGEON REPAIRED THE DEFECT. PER THE SURGEON, HE THOUGHT THAT THE LAA COULD HAVE EVULSED FROM THE LA WHILE CPR WAS BEING PERFORMED SECONDARY TO THE MANIPULATION. THE PATIENT EXPIRED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291785 LARIAT+ SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death