BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23404566 · Received October 28, 2025

    Report

    Report Number
    3032814119-2025-00017
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 28, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    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, 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.

    Description of Event or Problem · 0

    THE PHYSICIAN TRIED TO DEPLOY AN 8 X 40 STENT. HE HAD DIFFICULTY TRYING TO DEPLOY THE STENT AND UN-SHEATHED THE CATHETER. THE PHYSICIAN COULD NOT DEPLOY THE STENT. THE PHYSICIAN PROCEEDED TO REMOVE THE STENT AND TRIED A 9 X 40. HE COULD NOT DEPLOY THE 9 X 40 STENT. THE PHYSICIAN DECIDED TO USE TWO (2) COMPETITOR STENTS TO FINISH THE CASE. NO HARM TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 0

    THE PHYSICIAN TRIED TO DEPLOY AN 8 X 40 STENT. HE HAD DIFFICULTY TRYING TO DEPLOY THE STENT AND UN-SHEATHED THE CATHETER. THE PHYSICIAN COULD NOT DEPLOY THE STENT. THE PHYSICIAN PROCEEDED TO REMOVE THE STENT AND TRIED A 9 X 40. HE COULD NOT DEPLOY THE 9 X 40 STENT. THE PHYSICIAN DECIDED TO USE TWO (2) COMPETITOR STENTS TO FINISH THE CASE. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown