CGUARD PRIME CAROTID STENT SYSTEM
Report
- Report Number
- 3032814119-2025-00037
- Event Type
- Malfunction
- Date Received
- December 30, 2025
- Date of Event
- December 2, 2025
- Report Date
- December 30, 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. A ROOT CAUSE INVESTIGATION WAS CONDUCTED FOR THIS EVENT WHICH INCLUDED A RETURNED PRODUCT VISUAL AND FUNCTIONAL ANALYSIS, 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.
IT WAS REPORTED DURING A TCAR CASE THAT PHYSICIAN HAD TO USE EXCESSIVE FORCE AT "BOTTOM OF HILL" (AFTER PRE RELEASE) TO TRY TO DEPLOY STENT. HE TRIED TWICE AFTER TAKING IT BACK TO TOP AND BACK DOWN. STENT DID NOT DEPLOY. ANOTHER INSPIREMD STENT WAS USED TO COMPLETE THE CASE.
IT WAS REPORTED DURING A TCAR CASE THAT PHYSICIAN HAD TO USE EXCESSIVE FORCE AT "BOTTOM OF HILL" (AFTER PRE RELEASE) TO TRY TO DEPLOY STENT. HE TRIED TWICE AFTER TAKING IT BACK TO TOP AND BACK DOWN. STENT DID NOT DEPLOY. ANOTHER INSPIREMD STENT WAS USED TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 575852 | CGUARD PRIME CAROTID STENT SYSTEM | CAROTID STENT SYSTEM | NIM | INSPIREMD LTD. | CND0940 | 07290120281943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |