BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23864495 · Received December 22, 2025

    Report

    Report Number
    3032814119-2025-00034
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 22, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, 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. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. AN INTERNAL LOT RECORD REVIEW AND CLINICAL IMAGING REVIEW WAS PERFORMED. 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.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A PROCEDURE ON THE RIGHT ICA LESION, NEARLY 100% OCCLUDED THAT THE PHYSICIAN TRIED FOR OVER AN HOUR TO CROSS THE LESION. THE WIRE WOULD GET HELD UP AND THE TIGHTEST SPOT NEAR A SHELF OF PLAQUE. FINALLY, WAS ABLE TO CROSS. SERIAL DILATED THE ARTERY WITH A 2.5 MM BALLOON TO CREATE A CHANNEL FOR THE SPIDER WIRE FILTER. PLACED FILTER. DEPLOYED CGUARD PRIME 8 X 40. STENT OPENED BUT IT LOOKED AS THOUGH IT DID NOT FULY OPEN MUCH DISTAL TO THE BIFURCATION. POST DILATED WITH A 6 X 20 BALLOON AND STENT FULLY OPENED. ONCE A POST-DILATION ANGIO WAS TAKEN TO LOOK AT THE LESION THERE WAS EXTRAVASATION NOTICED NEAR WHERE THE TIGHTEST SPOT WAS. DOCTOR THEN PUT UP A BALLOON TO TAMPONADE THE ARTERY FROM INSIDE THE VESSEL. HELD BALLOON FOR 5 MINUTE. EXTRAVASATION IMPROVED BUT DOCTOR WANTED ANOTHER STENT TO COVER. PLACED ANOTHER CGUARD PRIME 8 X 40. TOOK POST STENT ANGIO AND DOCTOR SATISFIED. DOCTOR DID NOT BLAME STENT AND SAID EITHER PLAQUE PUSHED OUT ON THE FRAGILE VESSEL WALLS AFTER POST DILATION ANGIOPLASTY OR HE WAS NOT TRUE LUMEN ALL THE WAY UP WITH HIS WIRE AND THAT COULD HAVE CAUSED THE ISSUE. DOCTOR WAS SATISFIED AFTER 2ND STENT PLACED AND FINISHED THE CASE WITH NO ADDITIONAL ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A PROCEDURE ON THE RIGHT ICA LESION, NEARLY 100% OCCLUDED THAT THE PHYSICIAN TRIED FOR OVER AN HOUR TO CROSS THE LESION. THE WIRE WOULD GET HELD UP AND THE TIGHTEST SPOT NEAR A SHELF OF PLAQUE. FINALLY, WAS ABLE TO CROSS. SERIAL DILATED THE ARTERY WITH A 2.5MM BALLOON TO CREATE A CHANNEL FOR THE SPIDER WIRE FILTER. PLACED FILTER. DEPLOYED CGUARD PRIME 8X40. STENT OPENED BUT IT LOOKED AS THOUGH IT DID NOT FULY OPEN MUCH DISTAL TO THE BIFURCATION. POST DILATED WITH A 6X20 BALLOON AND STENT FULLY OPENED. ONCE A POST-DILATION ANGIO WAS TAKEN TO LOOK AT THE LESION THERE WAS EXTRAVASATION NOTICED NEAR WHERE THE TIGHTEST SPOT WAS. DOCTOR THEN PUT UP A BALLOON TO TAMPONADE THE ARTERY FROM INSIDE THE VESSEL. HELD BALLOON FOR 5 MINUTE. EXTRAVASATION IMPROVED BUT DOCTOR WANTED ANOTHER STENT TO COVER. PLACED ANOTHER CGUARD PRIME 8X40. TOOK POST STENT ANGIO AND DOCTOR SATISFIED. DOCTOR DID NOT BLAME STENT AND SAID EITHER PLAQUE PUSHED OUT ON THE FRAGILE VESSEL WALLS AFTER POST DILATION ANGIOPLASTY OR HE WAS NOT TRUE LUMEN ALL THE WAY UP WITH HIS WIRE AND THAT COULD HAVE CAUSED THE ISSUE. DOCTOR WAS SATISFIED AFTER 2ND STENT PLACED AND FINISHED THE CASE WITH NO ADDITIONAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85220 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND0840

    Patients

    Seq Age Sex Outcome Treatment
    1