BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23383945 · Received October 24, 2025

    Report

    Report Number
    3032814119-2025-00016
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    August 21, 2025
    Report Date
    October 24, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, 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 INTERNAL LOT RECORD REVIEW AND CLINICAL CASE IMAGING REVIEW. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT FDA CODE 4315.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS.

    Description of Event or Problem · 0

    DURING A TRANS ULNAR ACCESS CASE, THE PHYSICIAN COULD NOT DEPLOY THE STENT. THE PHYSICIAN REMOVED THE STENT AND TRIED A TRANS FEMORAL APPROACH WHICH RESULTED ON A NON-DEPLOYMENT AS WELL. THE PHYSICIAN PROCEEDED TO ATTEMPT THE USE OF ANOTHER STENT USING THE TRANS FEMORAL APPROACH. THE STENT COULD NOT BE DEPLOYED. THE PHYSICIAN USED A COMPETITOR STENT TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED. THE PHYSICIAN WAS ABLE TO DEPLOY THE STENTS OUTSIDE THE BODY.

    Description of Event or Problem · 0

    DURING A TRANS ULNAR ACCESS CASE, THE PHYSICIAN COULD NOT DEPLOY THE STENT. THE PHYSICIAN REMOVED THE STENT AND TRIED A TRANS FEMORAL APPROACH WHICH RESULTED ON A NON-DEPLOYMENT AS WELL. THE PHYSICIAN PROCEEDED TO ATTEMPT THE USE OF ANOTHER STENT USING THE TRANS FEMORAL APPROACH. THE STENT COULD NOT BE DEPLOYED. THE PHYSICIAN USED A COMPETITOR STENT TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED. THE PHYSICIAN WAS ABLE TO DEPLOY THE STENTS OUTSIDE THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703653 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND1040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown