BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CGUARD PRIME CAROTID STENT SYSTEM

    MDR report key: 23200112 · Received October 2, 2025

    Report

    Report Number
    3032814119-2025-00005
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 2, 2025
    Manufacturer
    INSPIREMD LTD.
    Product Code
    NIM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, 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 RETURNED PRODUCT VISUAL AND FUNCTIONAL ANALYSIS AND INTERNAL LOT RECORD 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 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 PROCEDURE, THE PHYSICIAN UTILIZED A GUIDING SHEATH AND PERFORMED PRE-DILATION WITH A BALLOON. UPON REMOVAL OF THE BALLOON, RESISTANCE WAS NOTED. DESPITE THIS, THE PHYSICIAN WAS ABLE TO ADVANCE THE STENT (CS-1431-24-05) TO THE LESION SITE WITHOUT ISSUE. DURING DEPLOYMENT, THE HANDLE LEVER TRANSITIONED SMOOTHLY FROM POSITION 1 TO POSITION 2. HOWEVER, WHEN ATTEMPTING TO DEPLOY THE STENT, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN APPLIED ADDITIONAL FORCE TO THE LEVER, WHICH RESULTED IN THE LEVER SNAPPING. THE STENT FAILED TO DEPLOY AND REMAINED ON THE CATHETER. THE DEVICE WAS UBSEQUENTLY REMOVED FROM THE PATIENT. A SECOND INSPIREMD STENT (CS-1431-24-04) WAS THEN USED AND SUCCEFULLY ADVANCED TO THE LESION SITE. WHILE DEPLOYING, THE PHYSICIAN AGAIN FELT RESISTANCE AND AT FIRST WOULDN'T DEPLOY. WITH ADDITIONAL SIGNIFICANT FORCE THE STENT EVENTUALLY DEPLOYED WHICH CAUSED THE STENT TO MISS THE INTENDED TARGET AREA, COVERING ONLY APPROXIMATELY 80% OF THE LESION. A DIFFERENT MANUFACTURERS STENT WAS USED TO TREAT THE REMAINING PORTION OF THE LESION. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    DURING A PROCEDURE, THE PHYSICIAN UTILIZED A GUIDING SHEATH AND PERFORMED PRE-DILATION WITH A BALLOON. UPON REMOVAL OF THE BALLOON, RESISTANCE WAS NOTED. DESPITE THIS, THE PHYSICIAN WAS ABLE TO ADVANCE THE STENT ((B)(6)) TO THE LESION SITE WITHOUT ISSUE. DURING DEPLOYMENT, THE HANDLE LEVER TRANSITIONED SMOOTHLY FROM POSITION 1 TO POSITION 2. HOWEVER, WHEN ATTEMPTING TO DEPLOY THE STENT, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN APPLIED ADDITIONAL FORCE TO THE LEVER, WHICH RESULTED IN THE LEVER SNAPPING. THE STENT FAILED TO DEPLOY AND REMAINED ON THE CATHETER. THE DEVICE WAS UBSEQUENTLY REMOVED FROM THE PATIENT. A SECOND INSPIREMD STENT ((B)(6)) WAS THEN USED AND SUCCESSFULLY ADVANCED TO THE LESION SITE. WHILE DEPLOYING, THE PHYSICIAN AGAIN FELT RESISTANCE AND AT FIRST WOULDN'T DEPLOY. WITH ADDITIONAL SIGNIFICANT FORCE THE STENT EVENTUALLY DEPLOYED WHICH CAUSED THE STENT TO MISS THE INTENDED TARGET AREA, COVERING ONLY APPROXIMATELY 80% OF THE LESION. A DIFFERENT MANUFACTURERS STENT WAS USED TO TREAT THE REMAINING PORTION OF THE LESION. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426806 CGUARD PRIME CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM INSPIREMD LTD. CND0840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention