BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23405472 · Received October 28, 2025

    Report

    Report Number
    3032814119-2025-00019
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 28, 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. 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 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

    VIA FEMORAL ACCESS, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, BUT DEPLOYMENT WAS UNSUCCESSFUL. THE LEVER REACHED STPE 1: PRE-RELEASE, BUT RESISTANCE WAS NOTED. UPON RETRACTING THE STRAIN RELIEF (BLUE PORTUION), THE SYSTEM RETRACTED INTO THE HANDLE WITHOUT DELOYING THE CATHETER. THE PHYSICIAN REMOVED THE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE USING ANOTHER INSPIREMD CND0840 STENT. THE CASE CONCLUDED WITHOUT PATIENT HARM. DURING THE PROCESS OF PACKAGING THE PRODUCT TO BE RETURNED IT WAS NOTED THAT IT SEEMS THAT THE STRAIN RELIEF DETACHED FROM THE DELIVERY SYSTEM.

    Description of Event or Problem · 0

    VIA FEMORAL ACCESS, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, BUT DEPLOYMENT WAS UNSUCCESSFUL. THE LEVER REACHED STPE 1: PRE-RELEASE, BUT RESISTANCE WAS NOTED. UPON RETRACTING THE STRAIN RELIEF (BLUE PORTUION), THE SYSTEM RETRACTED INTO THE HANDLE WITHOUT DELOYING THE CATHETER. THE PHYSICIAN REMOVED THE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE USING ANOTHER INSPIREMD CND0840 STENT. THE CASE CONCLUDED WITHOUT PATIENT HARM. DURING THE PROCESS OF PACKAGING THE PRODUCT TO BE RETURNED IT WAS NOTED THAT IT SEEMS THAT THE STRAIN RELIEF DETACHED FROM THE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028216 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND0840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown