BEUDAMED
    FDA Adverse Event Death Summary report: N

    LABIAT+ SUTURE DELIVERY DEVICE

    MDR report key: 4725966 · Received April 22, 2015

    Report

    Report Number
    3005802238-2015-00003
    Event Type
    Death
    Date Received
    April 22, 2015
    Date of Event
    March 23, 2015
    Report Date
    April 21, 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 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 SPECS PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE UNDERGOING LAA CLOSURE WITH THE LARIAT DEVICE. PT'S MEDICAL HISTORY INCLUDED 5 TIA'S, 2 CVA'S, ATRIAL FIBRILLATION, HYPERTENSION, DIABETES, HYPERLIPIDEMIA, GI BLEEDS AND A COLON RESECTION. THE PT'S CURRENT MEDICAL REGIMEN INCLUDED ADA, AMIODARONE AND DIGOXIN. THE PHYSICIANS DISCUSSED THE PROCEDURE WITH THE PT INCLUDING THE INCREASED RISK DUE TO ADVANCED AGE AND CO-MORBIDITIES. THE LARIAT DEVICE WAS ADVANCED AND PLACED UNREMARKABLY AROUND THE LAA. THE DEVICE SNARE WAS CLOSED AND THE SUTURE MANUALLY DEPLOYED. THE TEE SHOWED NO FLOW AND THE PT WAS STABLE. THE PHYSICIAN CONTINUED TO PROCEED AND TENSIONED THE SUTURE ONE TIME. AFTER TENSIONING, THE PT'S BLOOD PRESSURE DROPPED AND AN EFFUSION WAS NOTED ON TEE. THE PHYSICIAN ATTEMPTED TO MANAGE THE EFFUSION; THE FAMILY REQUESTED THAT THE PT BE MADE A DNR. THE FAMILY REFUSED SURGICAL INTERVENTION OR RESUSCITATION MANEUVERS. THE PT EXPIRED ON (B)(6) 2015. THE PHYSICIAN COMMENTED THAT THE ADVANCED AGE OF THE PT CONTRIBUTED TO THE FRIABILITY OF THE TISSUE THUS TENSIONING MAY HAVE CAUSED THE TISSUE TO TEAR RESULTING IN THE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267169 LABIAT+ SUTURE DELIVERY DEVICE REMOTE SUTURE DELIVERY DEVICE GAT SENTREHEART INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death