BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANASTOCLIP AC CLOSURE SYSTEM

    MDR report key: 19871190 · Received July 31, 2024

    Report

    Report Number
    1220948-2024-00131
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 31, 2024
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    FZP
    PMA / PMN Number
    K962043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE NOT RECEIVED THE DEVICE FOR INVESTIGATION. THEREFORE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. PER THE IFU: "SQUEEZE THE LEVERS TOGETHER FULLY UNTIL A DISCERNIBLE CLICK IS FELT. FAILURE TO SQUEEZE THE LEVERS COMPLETELY CAN RESULT IN CLIP MALFORMATION AND POSSIBLE BLEEDING OR LEAKAGE. CHECK TIGHTNESS OF CLIP PLACEMENT. TISSUE SHOULD COMPLETELY FILL CLIP OPENING AND CLIP SHOULD NOT LOOSELY ROCK SIDE TO SIDE." THE LOT HISTORY RECORD FOR THE DEVICE WAS REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. DUE TO THE INCREASED RATE OF OCCURRENCE OF THIS ISSUE, CAPA 2022-033 HAS PREVIOUSLY BEEN IMPLEMENTED TO REDUCE THE OCCURRENCE OF THIS ISSUE. NOTE: THIS IS REPORT 1 OF 5 RELATED TO THE FIRST DEVICE USED IN THE EVENT. REPORTS 1220948-2024-00151, 1220948-2024-00152, 1220948-2024-00153, AND 1220948-2024-00154 WERE SUBMITTED FOR THE SECOND, THIRD, FOURTH, AND FIFTH DEVICES INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    IN 5 DIFFERENT SURGERIES PERFORMED THIS YEAR, IT WAS REPORTED THAT THE CEREBROSPINAL FLUID LEAK OCCURRED AT THE LOCATION WHERE THE ANASTOCLIP DEVICE WAS USED. DURING THE SURGERY, THE LEVER OF ANASTOCLIP AC WAS HELD FIRMLY AND THE CLIPS WERE SECURELY ATTACHED TO THE DURA MATTER. HOWEVER, ON THE DAY AFTER SURGERY, IT FOUND THAT A LIQUID LIKE WATER LEAKED FROM THE ANASTOMOSIS. WHEN GRASPED THE CLIPS WITH TWEEZERS, IT SEEMS THAT IT CAME OFF EASILY. THE CLIPS WERE PLACED CLOSE TOGETHER SO THAT THERE WERE NO GAPS BETWEEN THEM. THERE WAS NO CHANGE IN TECHNIQUE FROM PREVIOUS METHODS. ADDITIONAL INFORMATION WAS REQUESTED BUT THE DOCTOR REFUSED TO PROVIDE ADDITIONAL DETAILS. NOTE: THIS IS REPORT 1 OF 5 RELATED TO THE FIRST DEVICE USED IN THE EVENT. REPORTS 1220948-2024-00151, 1220948-2024-00152, 1220948-2024-00153, AND 1220948-2024-00154 WERE SUBMITTED FOR THE SECOND, THIRD, FOURTH, AND FIFTH DEVICES INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958150 ANASTOCLIP AC CLOSURE SYSTEM CLOSURE SYSTEM FZP LEMAITRE VASCULAR, INC. ANC2416

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other