Device brand name · Carotid stent system
CGuard Prime Carotid Stent System: medical device reports filed with FDA
187 reports name it, 2025–2026. Manufacturer given most often on reports: Inspiremd. Product code NIM.
- 187
- device reports naming the brand
- 0% of all MAUDE reports · about 187 a year
- 187
- reports, 12 months to August 2026
- 0 in the 12 months before
- 81.8%
- classified as malfunction
- 26.7% across the product code
- 1.1%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 187 reports that name the brand "CGuard Prime Carotid Stent System" (carotid stent system), received between September 2025 and August 2026; the manufacturer given most often on reports is Inspiremd. Spellings of one product vary from report to report.
187 reports arrived in the 12 months to August 2026, with none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (81.8%), injury (17.1%) and death (1.1%); across all stent, carotid reports (product code NIM) death is recorded in 8% and malfunction in 26.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are activation failure (36.9%), difficult or delayed activation (29.4%) and insufficient device problem information (23%). The patient problems coded most often are obstruction/occlusion, thrombosis/thrombus and stroke/cva. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,728 reports carrying product code NIM. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Activation failure | 69 | 36.9% | 2.5% |
| Difficult or delayed activation | 55 | 29.4% | 0.8% |
| Insufficient device problem information | 43 | 23% | 2.1% |
| Malposition of device | 12 | 6.4% | 0.6% |
| Breakthe device broke | 9 | 4.8% | 3.3% |
| Activation, positioning or separation problem | 5 | 2.7% | 3.8% |
| Loss of or failure to bond | 2 | 1.1% | 0.1% |
| Material deformation | 2 | 1.1% | 1.9% |
| Material separation | 2 | 1.1% | 1.1% |
| Positioning problem | 2 | 1.1% | 0.6% |
| Difficult to insertthe device was hard to insert | 1 | 0.5% | 0.4% |
| Difficult to removethe device was hard to remove | 1 | 0.5% | 4.2% |
| Fracturea broken bone | 1 | 0.5% | 0.8% |
| Manufacturing, packaging or shipping problem | 1 | 0.5% | 0% |
| Mechanical problema mechanical problem | 1 | 0.5% | 0.5% |
| Poor visibility | 1 | 0.5% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Obstruction/occlusion | 5 | 2.7% |
| Thrombosis/thrombus | 5 | 2.7% |
| Stroke/cva | 4 | 2.1% |
| Ischemia stroke | 3 | 1.6% |
| Vascular dissection | 2 | 1.1% |
| Arteriosclerosis/ atherosclerosis | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | CGuard Prime Carotid Stent System | Product code NIM | All MAUDE reports |
|---|---|---|---|
| Reports | 187 | 8,728 | 26,136,888 |
| Share of that pool | — | 2.1% | 0% |
| Classified as death, per 1,000 reports | 11 | 80 | 9 |
| Classified as injury | 17.1% | 64.8% | 36.2% |
| Classified as malfunction | 81.8% | 26.7% | 62.3% |
| Filed by the manufacturer | 51.9% | 98.2% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code NIM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Rx Acculink Carotid Stent System | 2,016 | 0 | 9.3% |
| Precise Pro Rx Carotid Stent System | 1,331 | 0 | 15.9% |
| Xact Carotid Stent System | 1,292 | 0 | 9.5% |
| Carotid WALLSTENT | 840 | 122 | 0.8% |
| Carotid Wallstent Monorail | 459 | 0 | 1.7% |
| Protege Rx Carotid Stent System | 442 | 54 | 6.3% |
| Precise Otw Nitinol Stent | 330 | 0 | 2.4% |
| Enroute Transcarotid Stent System | 218 | 0 | 2.8% |
| Precise Rx Nitinol Stent | 300 | 0 | 17.7% |
| Nexstent Monorail | 187 | 0 | 2.7% |
| Rx Accunet Embolic Protection System | 429 | 0 | 2.1% |
| GORE EXCLUDER AAA Endoprosthesis | 9,590 | 633 | 4.8% |
| Multi-Link Rx Vision Coronary Stent System | 1,875 | 0 | 4.2% |
| Protege Gps Self-Expanding Stent System 035 Standard | 178 | 9 | 2.8% |
| Angioguard Rx Emboli Capture Guidewire System | 317 | 0 | 0.6% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about CGuard Prime Carotid Stent System reports
How many FDA reports name CGuard Prime Carotid Stent System?
187 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 187 in the latest 12 months.
What kinds of events are reported?
malfunction (81.8%), injury (17.1%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation failure (36.9%), difficult or delayed activation (29.4%), insufficient device problem information (23%), malposition of device (6.4%) and break (4.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (51.9%), distributor reports (47.6%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that CGuard Prime Carotid Stent System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.