BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23803935 · Received December 15, 2025

    Report

    Report Number
    3032814119-2025-00030
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 15, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    UDI-DI
    07290120281943
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, 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, 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 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 A TRANSFEMORAL CASE, THE PHYSICIAN WAS ABLE TO TRACK INTO THE TARGETED LESION. THE PHYSICIAN STARTED THE DEPLOYMENT PROCESS, WAS ABLE TO MOVE THE LEVER TO THE PRE-RELEASE STAGE, HOWEVER IT COULD NOT MOVE LEVER PAST THE PRE-RELEASE STEP AND COULD NOT DEPLOY STENT. THE PHYSICIAN PROCEEDED TO REMOVE THE SYSTEM AND PLACE THE SYSTEM IN THE BACK TABLE. HE TRIED TO DEPLOY THE STENT, BUT HE COULD NOT. HE PROCEEDED TO PUSH THE STRAIN RELIEF BACKWARDS AND THE STENT DEPLOYED. THE CASE WAS COMPLETED USING AN INSPIREMD CND0840. PHYSICIAN WAS ABLE TO DEPLOY THE STENT WITH SOME RESISTANCE. NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRANSFEMORAL CASE, THE PHYSICIAN WAS ABLE TO TRACK INTO THE TARGETED LESION. THE PHYSICIAN STARTED THE DEPLOYMENT PROCESS, WAS ABLE TO MOVE THE LEVER TO THE PRE-RELEASE STAGE, HOWEVER IT COULD NOT MOVE LEVER PAST THE PRE-RELEASE STEP AND COULD NOT DEPLOY STENT. THE PHYSICIAN PROCEEDED TO REMOVE THE SYSTEM AND PLACE THE SYSTEM IN THE BACK TABLE. HE TRIED TO DEPLOY THE STENT, BUT HE COULD NOT. HE PROCEEDED TO PUSH THE STRAIN RELIEF BACKWARDS AND THE STENT DEPLOYED. THE CASE WAS COMPLETED USING AN INSPIREMD CND0840. PHYSICIAN WAS ABLE TO DEPLOY THE STENT WITH SOME RESISTANCE. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291761 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND0940 07290120281943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown