BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23466687 · Received November 4, 2025

    Report

    Report Number
    3032814119-2025-00022
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 4, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    UDI-DI
    07290120281905
    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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A FEMORAL ACCESS CASE TO TREAT THE RIGHT SIDE, THAT THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, BUT DEPLOYMENT WAS UNSUCCESSFUL. THE LEVER BINDED AND WOULD NOT MOVE. THE PHYSICIAN REMOVED THE DEVICE AND SUCCESSFULLY COMPLETED THE PROCDURE USING A COMPETITOR STENT. THE CASE CONCLUDED WITHOUT PATIENT HARM. THE DEVICE COULD NOT BE DEPLOYED OUTSIDE THE BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A FEMORAL ACCESS CASE TO TREAT THE RIGHT SIDE, THAT THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, BUT DEPLOYMENT WAS UNSUCCESSFUL. THE LEVER BINDED AND WOULD NOT MOVE. THE PHYSICIAN REMOVED THE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE USING A COMPETITOR STENT. THE CASE CONCLUDED WITHOUT PATIENT HARM. THE DEVICE COULD NOT BE DEPLOYED OUTSIDE THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104273 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND0840 07290120281905

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown