ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
Report
- Report Number
- 2124215-2026-07134
- Event Type
- Injury
- Date Received
- February 9, 2026
- Date of Event
- January 12, 2026
- Report Date
- February 24, 2026
- Manufacturer
- SILK ROAD MEDICAL
- Product Code
- NTE
- UDI-DI
- 00811311021062
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPDATED FIELDS: H6 - EVALUATION METHOD CODES; EVALUATION CONCLUSION CODES.
IT WAS REPORTED THAT A DISSECTION OCCURRED RESULTING IN THE CONVERSION OF THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING INSERTION OF THE ARTERIAL SHEATH OF THE NPS, A DISSECTION WAS CREATED IN THE COMMON CAROTID ARTERY (CCA). THE PHYSICIAN ELECTED TO CONVERT THE TCAR PROCEDURE TO A CEA PROCEDURE.
IT WAS REPORTED THAT A DISSECTION OCCURRED RESULTING IN THE CONVERSION OF THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). AN ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING INSERTION OF THE ARTERIAL SHEATH OF THE NPS, A DISSECTION WAS CREATED IN THE COMMON CAROTID ARTERY (CCA). THE PHYSICIAN ELECTED TO CONVERT THE TCAR PROCEDURE TO A CEA PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 355373 | ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM | EMBOLIC PROTECTION FILTERING GUIDEWIRE | NTE | SILK ROAD MEDICAL | FG12531 | 0000306905 | 00811311021062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female | Required Intervention |