BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23595532 · Received November 19, 2025

    Report

    Report Number
    3032814119-2025-00024
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 28, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    UDI-DI
    07290120281943
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS. A FOLLOW UP REPORT FOR 3032814119-2025-00024 WAS SUBMITTED USING AN INCORRECT OUT OF SEQUENCE MDR NUMBER OF 3032814119-2025-00025. THIS HAS ALSO BEEN IDENTIFIED IN THE 3032814119-2025-00025 MDR. THE SUPPLEMENTAL FOLLOW-UP INFORMATION FOR THIS CORRECT MDR 3032814119-2025-00024 REPORT IS AS FOLLOWS: A ROOT CAUSE INVESTIGATION WAS CONDUCTED FOR THIS EVENT WHICH INCLUDED A RETURNED PRODUCT VISUAL AND FUNCTIONAL ANALYSIS, CLINICAL IMAGING, AND INTERNAL LOT RECORD REVIEW. THE RESULTS INDICATE THAT THIS LOT WAS PROCESSED WITHOUT INCIDENT, AND THE DEVICE CONFORMS TO THE SPECIFICATIONS. A ROOT CAUSE FOR THE DIFFICULTY DEPLOYING THE STENT COULD NOT BE FOUND AND EITHER IT WAS NOT CONFIRMED THAT THERE WAS A PROBLEM WITH THE DEVICE, OR IT WAS CONFIRMED THAT THERE WAS NO PROBLEM WITH THE DEVICE FDA CODE 67. THE ONLY CHANGE TO THIS REPORT IS THE USE OF CLINICAL IMAGING AS PART OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE TERRITORY MANAGER BY THE PHYSICIAN THAT IN A TRANSFEMORAL CASE WHERE HE WAS ASSISTING HIS NEW PARTNER, THEY EXPERIENCED RESISTANCE IN THE HANDLE. THE HANDLE WAS TIGHT, AND HE MISSED A PORTION OF THE LESION DURING THE DEPLOYMENT. PHYSICIAN BELIEVES THAT HE PUSHED OUT THE STENT AS HE WAS STRUGGLING WITH THE HANDLE. CASE WAS COMPLETED WITH A COMPETITORS STENT. NO HARM TO THE PATIENT. THE CASE HAPPENED DURING THE MONTH OF OCTOBER BUT EXACT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    THE PHYSICIAN WAS USING A 6F NEURON MAX SHEATH IN THE COMMON CAROTID. HE DEPLOYED THE NAV6 EPD. HE THEN PRE-DILATED WITH A 2.5 BALLOON. HE BROUGHT THE CGUARD STENT UP AND POSITIONED IT WHERE HE WANTED. HE PERFORMED THE PRE-RELEASE AND HE DID NOT HEAR OR FEEL A SOLID "CLICK". HE THEN PUSHED THE PRE-RELEASE BACK UP AND ATTEMPTED TO PULL IT DOWN AGAIN IN AN EFFORT TO GET A SOLID "CLICK". HE COULD NOT GET THE CLICK AND HE TRIED TO START DEPLOYING THE STENT. HE EXPERIENCED SIGNIFICANT RESISTANCE. HE DECIDED TO REOMOVE THE DEVICE AND COMPLETED THE PROCEDURE WITH A OTHER MANFACTURERS STENT. HE THEN POST DIALTED WITH A 5MM AVIATOR BALLOON. NO ADVERSE EVENTS OCCURED DURING OR AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65135 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND0840 07290120281943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown