BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23256993 · Received October 9, 2025

    Report

    Report Number
    3032814119-2025-00009
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 9, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, 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 WHICH INCLUDED A RETURNED PRODUCT VISUAL AND FUNCTIONAL ANALYSIS, 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 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

    DURING THE PRE-RELEASE OF THE FIRST STENT, NO CLICK WAS HEARD AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN STILL TRIED TO DEPLOY IT AND ENCOUNTERED RESISTANCE IN THE LEVER. HE COULD NOT REACH THE SECOND RELEASE STAGE. THEREFORE, THE STENT WAS REMOVED, AND A SECOND STENT WAS OPENED. THE SECOND STENT WAS INSERTED, AND THE PHYSICIAN WAS ABLE TO COMPLETE THE FIRST RELEASE (HERING THE AUDIBLE CLICK) BUT ENCOUNTERED EXTREME RESISTANCE AND COULD NOT COMPLETE THE SECOND RELEASE STAGE. THE STENT WAS REMOVED. THE CAE WAS COMPLETED USING A DIFFERENT MANUFACTURERS STENT. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    DURING THE PRE-RELEASE OF THE FIRST STENT, NO CLICK WAS HEARD AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN STILL TRIED TO DEPLOY IT AND ENCOUNTERED RESISTANCE IN THE LEVER. HE COULD NOT REACH THE SECOND RELEASE STAGE. THEREFORE, THE STENT WAS REMOVED, AND A SECOND STENT WAS OPENED. THE SECOND STENT WAS INSERTED, AND THE PHYSICIAN WAS ABLE TO COMPLETE THE FIRST RELEASE (HERING THE AUDIBLE CLICK) BUT ENCOUNTERED EXTREME RESISTANCE AND COULD NOT COMPLETE THE SECOND RELEASE STAGE. THE STENT WAS REMOVED. THE CAE WAS COMPLETED USING A DIFFERENT MANUFACTURERS STENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481286 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND0840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown