BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23803692 · Received December 15, 2025

    Report

    Report Number
    3032814119-2025-00029
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 15, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    UDI-DI
    07290120281981
    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. 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 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 THE FOLLOWING: PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE. PATIENT IS DOING WELL; HOWEVER, THE NOSE OF THE STENT POST DEPLOYMENT WA GETTING STUCK PRIOR RO POST DILATION. HE USED A 3.5 BALLOON FREE IN A MODERATELY CALCIFIED LESION, FOLLOWED WITH A 5.5 BALLOON. DURING THE DEPLOYMENT PROCESS THE STENT DID JUMP BUT DID NOT MIS THE (STENOSIS) LESION; HOWEVER, IT DID NOT DEPLOY AT THE DESIRED LOCATION AND HAD TO EXPAND THE STENT. THE PHYSICIAN USED A COMPETITOR STENT TO COVER THE PROXIMAL COMMON CAROTID. THE PHYSICIAN DID NOT EXPERIENCE RESISTANCE. THE NOSE CONE IS BULKY PER PHYSICIAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THE FOLLOWING: PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE. PATIENT IS DOING WELL; HOWEVER, THE NOSE OF THE STENT POST DEPLOYMENT WA GETTING STUCK PRIOR RO POST DILATION. HE USED A 3.5 BALLOON FREE IN A MODERATELY CALCIFIED LESION, FOLLOWED WITH A 5.5 BALLOON. DURING THE DEPLOYMENT PROCESS THE STENT DID JUMP BUT DID NOT MIS THE (STENOSIS) LESION, HOWEVER IT DID NOT DEPLOY AT THE DESIRED LOCATION AND HAD TO EXPAND THE STENT. THE PHYSICIAN USED A OMPETITOR STENT TO COVER THE PROXIMAL COMMON CAROTID. THE PHYSICIAN DID NOT EXPEREINCE RESISTANCE. THE NOSE CONE IS BULKY PER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606784 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND1040 07290120281981

    Patients

    Seq Age Sex Outcome Treatment
    1