Device brand name · Enroute tss
Enroute Transcarotid Stent System: medical device reports filed with FDA
218 reports name it, 2017–2025. Manufacturer given most often on reports: Silk Road Medical. Product code NIM.
- 218
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 25 in the 12 months before
- 6.9%
- classified as malfunction
- 26.7% across the product code
- 2.8%
- classified as death, as reported
- 6 reports · not verified by FDA
FDA's MAUDE database holds 218 reports that name the brand "Enroute Transcarotid Stent System" (enroute tss), received between June 2017 and March 2025; the manufacturer given most often on reports is Silk Road Medical. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 25 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 injury (90.4%), malfunction (6.9%) and death (2.8%); 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 material deformation (6%), break (4.6%) and fracture (4.1%). The patient problems coded most often are thrombosis/thrombus, ischemia stroke 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.
By year received
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 |
|---|---|---|---|
| Material deformation | 13 | 6% | 1.9% |
| Breakthe device broke | 10 | 4.6% | 3.3% |
| Fracturea broken bone | 9 | 4.1% | 0.8% |
| Difficult to removethe device was hard to remove | 4 | 1.8% | 4.2% |
| Loss of or failure to bond | 4 | 1.8% | 0.1% |
| Improper or incorrect procedure or method | 2 | 0.9% | 0.4% |
| Material separation | 2 | 0.9% | 1.1% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 0.9% | 0.2% |
| Unintended movement | 2 | 0.9% | 0% |
| Collapse | 1 | 0.5% | 0% |
| Device-device incompatibility | 1 | 0.5% | 0.2% |
| Malposition of device | 1 | 0.5% | 0.6% |
| Material split, cut or torn | 1 | 0.5% | 0.1% |
| Patient device interaction problem | 1 | 0.5% | 0% |
| Therapeutic or diagnostic output failure | 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 |
|---|---|---|
| Thrombosis/thrombus | 99 | 45.4% |
| Ischemia stroke | 78 | 35.8% |
| Stroke/cva | 31 | 14.2% |
| Muscle weakness/atrophy | 22 | 10.1% |
| Brain injury | 16 | 7.3% |
| Obstruction/occlusion | 15 | 6.9% |
| Vascular dissection | 15 | 6.9% |
| Dysphasia | 14 | 6.4% |
| Thrombosis | 9 | 4.1% |
| Low blood pressure/ hypotension | 7 | 3.2% |
| Convulsion/seizure | 5 | 2.3% |
| Foreign body in patientpart of a device left in the patient | 5 | 2.3% |
| Extravasation | 4 | 1.8% |
| Restenosis | 4 | 1.8% |
| Speech disordera speech problem | 4 | 1.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Enroute Transcarotid Stent System | Product code NIM | All MAUDE reports |
|---|---|---|---|
| Reports | 218 | 8,728 | 26,136,888 |
| Share of that pool | — | 2.5% | 0% |
| Classified as death, per 1,000 reports | 28 | 80 | 9 |
| Classified as injury | 90.4% | 64.8% | 36.2% |
| Classified as malfunction | 6.9% | 26.7% | 62.3% |
| Filed by the manufacturer | 99.5% | 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% |
| Precise Rx Nitinol Stent | 300 | 0 | 17.7% |
| CGuard Prime Carotid Stent System | 187 | 187 | 1.1% |
| 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 Enroute Transcarotid Stent System reports
How many FDA reports name Enroute Transcarotid Stent System?
218 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (90.4%), malfunction (6.9%) and death (2.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material deformation (6%), break (4.6%), fracture (4.1%), difficult to remove (1.8%) and loss of or failure to bond (1.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) 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 Enroute Transcarotid 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.