Devices › Temporary carotid catheter for embolic capture
Device brand name · Temporary carotid catheter for embolic capture
ENROUTE Transcarotid Neuroprotection System: medical device reports filed with FDA
660 reports name it, 2016–2026. Manufacturer given most often on reports: Silk Road Medical. Product code NTE.
- 660
- device reports naming the brand
- 0% of all MAUDE reports · about 64 a year
- 130
- reports, 12 months to August 2026
- 145 in the 12 months before
- 4.1%
- classified as malfunction
- 34.8% across the product code
- 2%
- classified as death, as reported
- 13 reports · not verified by FDA
FDA's MAUDE database holds 660 reports that name the brand "ENROUTE Transcarotid Neuroprotection System" (temporary carotid catheter for embolic capture), received between April 2016 and August 2026; the manufacturer given most often on reports is Silk Road Medical. Spellings of one product vary from report to report.
130 reports arrived in the 12 months to August 2026, down 10% from 145 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 (93.9%), malfunction (4.1%) and death (2%); across all temporary carotid catheter for embolic capture reports (product code NTE) death is recorded in 2.1% and malfunction in 34.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device dislodged or dislocated (3.2%), difficult to insert (2.6%) and material deformation (1.7%). The patient problems coded most often are vascular dissection, ischemia stroke and muscle weakness/atrophy. 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 5,335 reports carrying product code NTE. 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 |
|---|---|---|---|
| Device dislodged or dislocated | 21 | 3.2% | 1.1% |
| Difficult to insertthe device was hard to insert | 17 | 2.6% | 3.4% |
| Material deformation | 11 | 1.7% | 1.5% |
| Detachment of device or device componentpart of the device came off | 9 | 1.4% | 4.3% |
| Difficult to advance | 6 | 0.9% | 2.5% |
| Improper or incorrect procedure or method | 5 | 0.8% | 5.7% |
| Material separation | 5 | 0.8% | 5.4% |
| Air/gas in device | 3 | 0.5% | 0% |
| Breakthe device broke | 3 | 0.5% | 4.1% |
| Insufficient flow or under infusion | 3 | 0.5% | 0% |
| Patient device interaction problem | 3 | 0.5% | 0.1% |
| Device markings/labelling problema problem with the device markings or label | 2 | 0.3% | 0.1% |
| Difficult or delayed positioning | 2 | 0.3% | 0.6% |
| Difficult to removethe device was hard to remove | 2 | 0.3% | 15.6% |
| Fluid/blood leak | 2 | 0.3% | 0% |
| Infusion or flow problema problem with flow or infusion | 2 | 0.3% | 0% |
| Unintended movement | 2 | 0.3% | 0% |
| Connection problema connection problem | 1 | 0.2% | 0% |
| Defective devicethe device was defective | 1 | 0.2% | 0.1% |
| Degraded | 1 | 0.2% | 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 |
|---|---|---|
| Vascular dissection | 389 | 58.9% |
| Ischemia stroke | 113 | 17.1% |
| Muscle weakness/atrophy | 73 | 11.1% |
| Stroke/cva | 52 | 7.9% |
| Dysphasia | 21 | 3.2% |
| Hematomaa collection of blood under the skin or in tissue | 18 | 2.7% |
| Brain injury | 15 | 2.3% |
| Thrombosis/thrombus | 15 | 2.3% |
| Low blood pressure/ hypotension | 14 | 2.1% |
| Hemorrhage/blood loss/bleeding | 9 | 1.4% |
| Paralysis | 9 | 1.4% |
| Embolism/embolus | 8 | 1.2% |
| High blood pressure/ hypertension | 8 | 1.2% |
| Myocardial infarctionheart attack | 8 | 1.2% |
| Extravasation | 7 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | ENROUTE Transcarotid Neuroprotection System | Product code NTE | All MAUDE reports |
|---|---|---|---|
| Reports | 660 | 5,335 | 26,136,888 |
| Share of that pool | — | 12.4% | 0% |
| Classified as death, per 1,000 reports | 20 | 21 | 9 |
| Classified as injury | 93.9% | 62.7% | 36.2% |
| Classified as malfunction | 4.1% | 34.8% | 62.3% |
| Filed by the manufacturer | 99.2% | 98.1% | 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 NTE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Emboshield Nav6 Embolic Protection System | 1,004 | 0 | 1.7% |
| Spider Fx | 649 | 65 | 2% |
| Angioguard Rx | 367 | 38 | 0.5% |
| Enroute Neuroprotection System | 331 | 0 | 0.6% |
| Angioguard Rx Emboli Capture Guidewire System | 317 | 0 | 0.6% |
| Angioguard Xp Emboli Capture Guidewire System | 275 | 0 | 0% |
| Emboshield Nav6 | 252 | 90 | 0.8% |
| Spiderfx Embolic Protection Device | 232 | 0 | 6% |
| Rx Accunet Embolic Protection System | 429 | 0 | 2.1% |
| FilterWire EZ | 507 | 71 | 0.4% |
| Filterwire Ez Emoblic Protection System | 164 | 0 | 1.8% |
| Abbott | 265 | 0 | 7.5% |
| Nanocross 0 14 Otw Pta Dilatation Catheter | 211 | 22 | 0.5% |
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 Neuroprotection System reports
How many FDA reports name ENROUTE Transcarotid Neuroprotection System?
660 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 130 in the latest 12 months.
What kinds of events are reported?
injury (93.9%), malfunction (4.1%) and death (2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (3.2%), difficult to insert (2.6%), material deformation (1.7%), detachment of device or device component (1.4%) and difficult to advance (0.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that ENROUTE Transcarotid Neuroprotection 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.