CGUARD PRIME CAROTID STENT SYSTEM
Report
- Report Number
- 3032814119-2025-00023
- Event Type
- Malfunction
- Date Received
- November 19, 2025
- Date of Event
- October 20, 2025
- Report Date
- November 19, 2025
- Manufacturer
- INSPIREMD LTD.
- Product Code
- NIM
- UDI-DI
- 07290120281943
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS.
DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS. SUPPLEMENTAL FOLLOW UP REPORT. THIS SUPPLEMENTAL FOLLOW UP REPORT IS TO PROVIDE ADDITIONAL INFORMATION TO CORRECT THE ORGINALLY REPORTED SERIAL NUMBER (B)(6) TO THE CORRECT SERIAL NUMBER (B)(6).
DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS. SUPPLEMENTAL FOLLOW UP REPORT. THIS SUPPLEMENTAL FOLLOW UP REPORT IS TO PROVIDE ADDITIONAL INFORMATION TO CORRECT THE ORGINALLY REPORTED SERIAL NUMBER (B)(6) TO THE CORRECT SERIAL NUMBER (B)(6). SUPPLEMENTAL FOLLOW UP REPORT. A ROOT CAUSE INVESTIGATION WAS CONDUCTED FOR THIS EVENT WHICH INCLUDED AN 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 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.
WHEN THE PHYSICIAN ADVANCED THE STENT, A GAP WAS OBSERVED BETWEEN THE NOSE CONE AND THE CATHETER. DURING THE PRE-RELEASE STEP, NO AUDIBLE CLICK WAS HEARD. UPON ATTEMPTING DEPLOYMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE. AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT AND SUBSEQUENTLY DEPLOYED OUTSIDE THE BODY ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A COMPETITOR STENT. CASE WAS TRANSFEMORAL.
WHEN THE PHYSICIAN ADVANCED THE STENT, A GAP WAS OBSERVED BETWEEN THE NOSE CONE AND THE CATHETER. DURING THE PRE-RELEASE STEP, NO AUDIBLE CLICK WAS HEARD. UPON ATTEMPTING DEPLOYMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE. AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT AND SUBSEQUENTLY DEPLOYED OUTSIDE THE BODY ON THE BACK TABLE. THE PROCDURE WAS COMPLETED USING A COMPETITOTR STENT. CAS WAS TRANSFEMORAL.
WHEN THE PHYSICIAN ADVANCED THE STENT, A GAP WAS OBSERVED BETWEEN THE NOSE CONE AND THE CATHETER. DURING THE PRE-RELEASE STEP, NO AUDIBLE CLICK WAS HEARD. UPON ATTEMPTING DEPLOYMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE. AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT AND SUBSEQUENTLY DEPLOYED OUTSIDE THE BODY ON THE BACK TABLE. THE PROCDURE WAS COMPLETED USING A COMPETITOTR STENT. CAS WAS TRANSFEMORAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1520297 | CGUARD PRIME CAROTID STENT SYSTEM | CAROTID STENT SYSTEM | NIM | INSPIREMD LTD. | CND0940 | 07290120281943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |