BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23360890 · Received October 22, 2025

    Report

    Report Number
    3032814119-2025-00011
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 22, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, 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 CLINICAL CASE IMAGING REVIEW. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A ROOT CAUSE FOR THE DIFFICULT 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

    DURING A STROKE CAROTID STENT PLACEMENT THE PHYSICIAN STATED THE DEVICE IS QUITE STIFF TO NAVIGATE. THE DEPLOYMENT SYSTEMS TAKES A LOT OF FORCE TO DEPLOY THE STENT. THE PROXIMAL END OF THE STENT IS VERY HARD TO VISUALIZE WITHIN THE DEPLOYMENT SYSTEM PRIOR TO DEPLOYMENT. THE PHYSICIAN COULD NOT SEE THE STENT WELL, AND ALTHOUGH THE STENT DEPLOYED, IT DID NOT DEPLOY WHERE HE WANTED. HE HAD TO USED A COMPETITOR'S STENT. NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    DURING A STROKE CAROTID STENT PLACEMENT THE PHYSICIAN STATED THE DEVICE IS QUITE STIFF TO NAVIGATE. THE DEPLOYMENT SYSTEMS TAKES ALOT OF FORCE TO DEPLOY THE STENT. THE PROXIMAL END OF THE STENT IS VERY HARD TO VISUALIZE WITHIN THE DEPLOYMENT SYSTEM PRIOR TO DEPLOYMENT. THE PHYSICIAN COULD NOT SEE THE STENT WELL, AND ALTHOUGH THE STENT DEPLOYED, IT DID NOT DEPLOY WHERE HE WANTED. HE HAD TO USED A COMPETITORS STENT. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303307 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND0940

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown