BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYSTEM

    MDR report key: 2081586 · Received May 9, 2011

    Report

    Report Number
    3003502395-2011-00007
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K093679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEFT ATRIAL APPENDAGE (LAA) WAS RETURNED WITH THE CLIP. THE APPENDAGE WAS MEASURED TO BE APPROXIMATELY 24 MM WIDE AT THE BASE AND 2.5 MM THICK. THE INSTRUCTIONS FOR USE (IFU) STATES IN THE WARNINGS - "5. DO NOT USE ON A LAA LESS THAN 29 MM IN WIDTH AND 1.0 MM WALL THICKNESS." THE APPENDAGE AS MEASURED FELL OUTSIDE THIS CRITERIA AND IS A POSSIBLE FACTOR IN THE EVENT.

    Description of Event or Problem · 1

    DURING THE INITIAL PROCEDURE ON 04/25/2011 AN ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION DEVICE WAS USED. THE LEFT ATRIAL APPENDAGE WAS REPORTED TO BE ELONGATED, BEING LARGER AT THE DISTAL (TIP) END THAN THE PROXIMAL (BASE) END. DURING THE CLIP PLACEMENT, THE PHYSICIAN HAD TO "STRETCH" THE APPENDAGE AND THE CLIP WAS PLACED ON THE LEFT ATRIAL APPENDAGE WITHOUT ISSUE. DURING EXTRACTION OF THE DEPLOYMENT TOOL THE PHYSICIAN STATED THAT THE CLIP WAS "BUMPED" AND THE CLIP TORE THE APPENDAGE. THE PATIENT WAS CONVERTED TO AN OPEN CHEST PROCEDURE AND PUT ON BYPASS. THE PHYSICIAN SUTURED THE TEAR AND THE PROCEDURE FINISHED WITHOUT FURTHER ISSUE. THERE WAS NO LONG TERM PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYSTEM CLIP, IMPLANTABLE FZP ATRICURE, INC. LAA040 29457

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R