BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEMAITRE VALVULOTOME

    MDR report key: 25107821 · Received May 6, 2026

    Report

    Report Number
    1220948-2026-00112
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 6, 2026
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    PMA / PMN Number
    K140042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IT REMAINS UNKNOWN WHETHER THE EVENT WAS RELATED TO A DEVICE MALFUNCTION OR TO PROCEDURAL FACTORS, SUCH AS SURGICAL TECHNIQUE. THE SURGEON COMMENTED THAT SUCH EVENTS CAN OCCASIONALLY OCCUR AND ACKNOWLEDGED THAT THE EVENT MAY HAVE BEEN RELATED TO TECHNICAL ERROR. THE PATIENT WAS REPORTED TO BE DOING WELL, AND NO FURTHER FOLLOW-UP WAS DEEMED NECESSARY. THE INSTRUCTIONS FOR USE (IFU) PROVIDE THE FOLLOWING WARNINGS REGARDING PROPER USE OF THE LEMAITRE VALVULOTOME: "DO NOT INSERT THE LEMAITRE VALVULOTOME INTO A VESSEL OR EXTRACT FROM A VESSEL IN THE OPEN POSITION. DO NOT ROTATE THE LEMAITRE VALVULOTOME IN A VESSEL. DO NOT ADVANCE THE LEMAITRE VALVULOTOME WITH THE BLADES IN THE OPEN POSITION. FAILURE TO SHEATH THE CUTTING BLADES AND CENTERING HOOPS PRIOR TO RETRACTING THE DEVICE FROM THE VEIN MAY CAUSE DAMAGE. A POTENTIAL COMPLICATION WHILE USING THE DEVICE IS VESSEL WALL PERFORATION." THE LOT NUMBER OF THE PRODUCT WAS NOT PROVIDED. THEREFORE, WE'RE UNABLE TO PERFORM A LOT REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FEMORAL-TO-POSTERIOR TIBIAL BYPASS PROCEDURE USING THE PATIENT'S GREATER SAPHENOUS VEIN, THE SURGEON INITIALLY PLANNED TO REVERSE THE VEIN BUT INSTEAD ELECTED TO USE A LEMAITRE VALVULOTOME DUE TO A SIZE MISMATCH. THE VALVOTOMY WAS PERFORMED ON THE BACK TABLE, AND DURING THE SECOND PASS, THE VALVULOTOME PERFORATED THE WALL OF THE VEIN NEAR A SECTION MEASURING APPROXIMATELY 2.5-3 MM IN DIAMETER. THE VEIN HAD BEEN INSPECTED PRIOR TO USE. AS A RESULT, A GORE PTFE GRAFT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL COMPLICATIONS OR PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226780 LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention