BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23466394 · Received November 4, 2025

    Report

    Report Number
    3032814119-2025-00021
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 4, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    UDI-DI
    07290120281981
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS. SUPPLEMENTAL FOLLOW UP REPORT. A ROOT CAUSE INVESTIGATION WAS CONDUCTED FOR THIS EVENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. AN INTERNAL LOT RECORD REVIEW WAS PERFORMED. A ROOT CAUSE FOR THE NON-DEPLOYED 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.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTERVENTION OF A PATIENT EXPERIENCING CLOTS, DISSECTION AND CALCIFICATION IN THE CAROTID, THE PHYSICIAN DECIDED TO USE A CND1040. THE PHYSICIAN WAS ABLE TO ADVANCE INTO THE LESION, BUT DURING DEPLOYMENT, RESISTANCE WAS EXPERIENCED, AND THE STENT DID NOT DEPLOY. THE PHYSICIAN DECIDED NOT TO CONTINUE APPLYING FORCE INTO THE DELIVERY SYSTEM AND PROCEEDED TO REMOVE THE CATHETER/STENT. THE PHYSICIAN FINISHED THE PROCEDURE WITH A COMPETITOR STENT. NO HARM TO THE PATIENT REPORTED. AFTER THE PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY THE STENT IN A FLAT TABLE. STENT DEPLOYED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTERVENTION OF A PATIENT EXPERIENCING CLOTS, DISSECTION AND CALCIFICATION IN THE CAROTID, THE PHYSICIAN DECIDED TO USE A CND1040. THE PHYSICIAN WAS ABLE TO ADVANCE INTO THE LESION, BUT DURING DEPLOYMENT, RESISTANCE WAS EXPERIENCED, AND THE STENT DID NOT DEPLOY. THE PHYSICIAN DECIDED NOT TO CONTINUE APPLYING FORCE INTO THE DELIVERY SYSTEM AND PROCEEDED TO REMOVE THE CATHETER/STENT. THE PHYSICIAN FINISHED THE PROCEDURE WITH A COMPETITOR STENT. NO HARM TO THE PATIENT REPORTED. AFTER THE PROCEDURE, THE PHYSICIAN TRIED TO DEPLOY THE STENT IN A FLAT TABLE. STENT DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609516 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND1040 07290120281981

    Patients

    Seq Age Sex Outcome Treatment
    1