BEUDAMED
    FDA Adverse Event Death Summary report: N

    ISOLATOR SYNERGY" ENCOMPASS CLAMP AND GUIDE

    MDR report key: 20286897 · Received September 23, 2024

    Report

    Report Number
    3011706110-2024-00054
    Event Type
    Death
    Date Received
    September 23, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    UDI-DI
    10840143905834
    PMA / PMN Number
    K210477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER, A DEVICE HISTORY REVIEW WAS CONDUCTED AND THERE IS NOTHING IN THE PRODUCT HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE SUBJECT COMPLAINT.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT AND AORTIC ROOT REPLACEMENT PROCEDURE, WITH CONCOMITANT POSTERIOR WALL ENCIRCLING ABLATION USING AN OLH VIA MEDIAN STERNOTOMY. WHEN PATIENT WAS TAKEN OFF CARDIOPULMONARY BYPASS BLEEDING WAS OBSERVED FROM THE LEFT ATRIUM AND BYPASS WAS REINITIATED. A TEAR WAS LOCATED ALONG THE ROOF OF THE LEFT ATRIUM AND REPAIRED WITH FOUR PLEDGETED SUTURES. THE PATIENT WAS THEN WEANED OFF BYPASS AND RETURNED TO THE INTENSIVE CARE UNIT. FOUR HOURS POST PROCEDURE, THE PATIENT WAS UNABLE TO BE EXTUBATED AND EXHIBITED SIGN OF A STROKE. A COMPUTED TOMOGRAPHY SCAN REVEALED A LEFT CEREBRAL INFARCT. THROMBUS WAS REMOVED FROM THE LEFT MIDDLE CEREBRAL ARTERY, AND IT WAS DISCOVERED THAT THERE WAS A 90% STENOSIS OF THAT VESSEL. THE PATIENT WAS PLACED ON SUPPORTIVE CARE AND DIED ON THE FOURTH POST OPERATIVE DAY. WHILE ATRICURE CANNOT CONFIRM THAT DEVICE CAUSED OR CONTRIBUTED TO PATIENT'S COMPLICATION OR DEMISE, WE ARE REPORTING PER CFR 21 PART 803. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136820 ISOLATOR SYNERGY" ENCOMPASS CLAMP AND GUIDE ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES OCL ATRICURE, INC. OLH 141322 10840143905834

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| D