CGUARD PRIME CAROTID STENT SYSTEM
Report
- Report Number
- 3032814119-2025-00025
- Event Type
- Malfunction
- Date Received
- November 28, 2025
- Report Date
- November 28, 2025
- Manufacturer
- INSPIREMD LTD.
- Product Code
- NIM
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE ANALYSIS AND INVESTIGATION IS IN-PROCESS. SUPPLEMENTAL FOLLOW UP REPORT 1. 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 DIFFICULTY DEPLOYING THE 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. SUPPLEMENTAL FOLLOW UP REPORT 2. THE PREVIOUS FOLLOW UP REPORT 1 ABOVE WAS SUBMITTED USING THIS INCORRECT MDR NUMBER OF 3032814119-2025-00025 AND IT SHOULD HAVE BEEN SUBMITTED UNDER 3032814119-2025-00024 FOR THAT REPORT. THE SUPPLEMENTAL FOLLOW UP INFORMATION FOR THIS CORRECT MDR 3032814119-2025-00025 REPORT IS AS FOLLOWS: A ROOT CAUSE INVESTIGATION WAS CONDUCTED FOR THIS EVENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND A SERIAL NUMBER WAS NOT PROVIDED FROM THE FIELD. 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.
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 DIFFICULTY DEPLOYING THE 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 TO THE TERRITORY MANAGER BY THE PHYSICIAN THAT IN A TRANSFEMORAL CASE WHERE HE WAS ASSISTING HIS NEW PARTNER, THEY EXPERIENCED RESISTANCE IN THE HANDLE. THE HANDLE WAS TIGHT, AND HE MISSED A PORTION OF THE LESION DURING THE DEPLOYMENT. PHYSICIAN BELIEVES THAT HE PUSHED OUT THE STENT AS HE WAS STRUGGLING WITH THE HANDLE. CASE WAS COMPLETED WITH A COMPETITORS STENT. NO HARM TO THE PATIENT. THE CASE HAPPENED DURING THE MONTH OF OCTOBER BUT EXACT DATE IS UNKNOWN.
IT WAS REPORTED TO THE TERRITORY MANAGER BY THE PHYSICIAN THAT IN A TRANSFEMORAL CASE WHERE HE WAS ASSISTING HIS NEW PARTNER, THEY EXPEREINCED RESISTANCE IN THE HANDLE. THE HANDLE WAS TIGHT, AND HE MISSED A PORTION OF THE LESION DURING THE DEPLOYMENT. PHYSICIAN BELIEVES THAT HE PUSHED OUT THE STENT AS HE WAS STRUGGLING WITH THE HANDLE. CASE WAS COMPLETED WITH A COMPETITOR'S STENT. NO HARM TO THE PATIENT. THE CASE HAPPENED DURING THE MONTH OF (B)(6) BUT EXACT DATE IS UNKNOWN.
IT WAS REPORTED TO THE TERRITORY MANAGER BY THE PHYSICIAN THAT IN A TRANSFEMORAL CASE WHERE HE WAS ASSISTING HIS NEW PARTNER, THEY EXPERIENCED RESISTANCE IN THE HANDLE. THE HANDLE WAS TIGHT, AND HE MISSED A PORTION OF THE LESION DURING THE DEPLOYMENT. PHYSICIAN BELIEVES THAT HE PUSHED OUT THE STENT AS HE WAS STRUGGLING WITH THE HANDLE. CASE WAS COMPLETED WITH A COMPETITORS STENT. NO HARM TO THE PATIENT. THE CASE HAPPENED DURING THE MONTH OF OCTOBER BUT EXACT DATE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289259 | CGUARD PRIME CAROTID STENT SYSTEM | CAROTID STENT SYSTEM | NIM | INSPIREMD LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |