BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23381119 · Received October 24, 2025

    Report

    Report Number
    3032814119-2025-00014
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    August 21, 2025
    Report Date
    October 24, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS.

    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, AND CLINICAL CASE IMAGING 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 THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT FDA CODE 4315.

    Description of Event or Problem · 0

    THE DEVICE WAS USED THROUGH A TRANSFEMORAL APPROACH ON THE PATIENT'S RIGHT SIDE. THE STENT WAS DEPLOYED SUCCESSFULLY. DURING DEPLOYMENT, RESISTANCE WAS NOTED ON THE LEVER OF THE HANDLE. DURING RETRACTION OF THE DELIVERY SYSTEM, TENSION/PRESSURE WAS EXPERIENCED. THE SYSTEM FRACTURED AT THE DISTAL END OF THE SYSTEM WHILE INSIDE THE PATIENT. THE PHYSICIAN USED AN ASPIRATION TECHNIQUE AND 6 CC TO REMOVE THE BROKEN DELIVERY SYSTEM FROM THE PATIENT. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE DEVICE WAS USED THROUGH A TRANSFEMORAL APPROACH ON THE PATIENT'S RIGHT SIDE. THE STENT WAS DEPLOYED SUCCESSFULLY. DURING DEPLOYMENT, RESISTANCE WAS NOTED ON THE LEVER OF THE HANDLE. DURING RETRACTION OF THE DELIVERY SYSTEM, TENSION/PRESSURE WAS EXPERIENCED. THE SYSTEM FRACTURED AT THE DISTAL END OF THE SYSTEM WHILE INSIDE THE PATIENT. THE PHYSICIAN USED AN ASPIRATION TECHNIQUE AND 6 CC TO REMOVE THE BROKEN DELIVERY SYSTEM FROM THE PATIENT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375917 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND0940

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown