BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23372244 · Received October 23, 2025

    Report

    Report Number
    3032814119-2025-00013
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    July 18, 2025
    Report Date
    October 23, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    UDI-DI
    07290120281943
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED FROM THE FIELD THAT THERE WERE NO ISSUES WITH PRE-RELEASE AND THEY WERE NOT ABLE TO CONFIRM IF THE DEVICE CLICKED/LOCKED AFTER PRE-RELEASE. DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS.

    Description of Event or Problem · 0

    TRIED TO GO RADIAL APPROACH THROUGH THE .087 PIRAEUS MEDICAL. DEPLOYED NAV 6EPD. WAS ABLE TO TRACK THE 9 X 40 CGUARD STENT TO THE LOCATION. DURING DEPLOYMENT OF THE STENT HE COULD NOT PULL THE LEVER BACK AND RELEASE THE STENT. AFTER TRYING VERY HARD TO RELEASE THE STENT WE DECIDED TO REMOVE THE PRODUCT. AS WE STARTED TO REMOVE THE PRODUCT THE 2 DISTAL RINGS OF THE STENT DEPLOYED AND PREVENTED US FROM REMOVING THE STENT. HE DECICDED TO PULL THE ENTIRE SYSTEM INCLUDING THE FLTER OUT OF THE BODY. AS WE BROUGHT EVERYTHING DOWN THE RADIAL ARTERY THE STENT DEPLOYED IN THE DISTAL RADIAL ARTERY. APPROXIMATELY 4-5 INCHES FROM THE WRIST. WE COMPLETED THE PROCEDURE FROM THE FEMORAL ACCESS WITH A COMPETITOR STENT AND THERE WAS NO CLINICAL IMPACT TO THE PATIENT. DURING THE FINAL RUNS OF THE CASE, WE DID AN ANGIOGRAM OF THE RADIAL ARTERY AND IT APPEARED THT THE RADIAL ARTERY OCCLUDED AT THE LOCATION OF THE STENT. THE PATIENTS HAND APPEARED NORMAL AND THE COLLATERAL FLOW FROM THE ULNAR ARTERY MORE THAN LIKELY WAS ADEQUATELY PERFUSED THE HAND AS REPORTED IN MANY STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699308 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. 07290120281943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown