BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23804282 · Received December 15, 2025

    Report

    Report Number
    3032814119-2025-00031
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 15, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    UDI-DI
    07290120281905
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS.

    Description of Event or Problem · 0

    DURING A TRANSFEMORAL PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE STENT, IT BECAME STUCK HALFWAY THROUGH AND WAS PARTIALLY DEPLOYED. THE PHYSICIAN MOVED THE BLUE STRAIN RELIEF WHICH ALLOWED THE STENT TO JUMP FORWARD, WHICH ALLOWED FULL DEPLOYMENT. THE STENT MOVED APPROXIMATELY 5-6MM FORWARD FROM THE INTENDED LOCATION BUT STILL COVERED THE TARGET LESION. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735599 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND0840 07290120281905

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown