ENROUTE TRANSCAROTID STENT
Report
- Report Number
- 2124215-2025-64592
- Event Type
- Injury
- Date Received
- September 15, 2025
- Date of Event
- August 7, 2025
- Report Date
- October 17, 2025
- Manufacturer
- SILK ROAD MEDICAL
- Product Code
- NIM
- UDI-DI
- 00811311021314
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
FURTHER INFORMATION WAS RECEIVED FOR THE STROKE TIMELINE WHICH ATTRIBUTES THE STROKE TO THE ENROUTE NEUROPROTECTION SYSTEM (NPS) WHICH IS CAPTURED IN MDR REPORT NUMBER 2124215-2025-64583. SINCE THE TIMELINE FOR THE STROKE EVENT IN RELATION TO THE TCAR PROCEDURE IS UNKNOWN, THE EVENT COULD NOT BE ATTRIBUTED TO EITHER THE ENROUTE STENT OR THE ENROUTE NEUROPROTECTION SYSTEM (NPS). AS A MOST-LIKELY DEVICE COULD NOT BE DETERMINED, AN MDR IS BEING REPORTED FOR BOTH DEVICES. PLEASE SEE MDR 2124215-2025-64583, WHICH CAPTURES THE ENROUTE NPS USED DURING THIS PROCEDURE. B3 - DATE OF EVENT: THE EVENT DATE WAS APPROXIMATED TO THE DATE BSC BECAME AWARE OF THE EVENT, 08/19/2025. D6A - IMPLANT DATE: THE IMPLANT DATE WAS APPROXIMATED TO THE DATE BSC BECAME AWARE OF THE EVENT, 08/19/2025. DETAILS OF THE EVENT, INCLUDING PATIENT STATUS AND PRODUCT INFORMATION, WERE NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT LOT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) NUMBER AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
SINCE THE TIMELINE FOR THE STROKE EVENT IN RELATION TO THE TCAR PROCEDURE IS UNKNOWN, THE EVENT COULD NOT BE ATTRIBUTED TO EITHER THE ENROUTE STENT OR THE ENROUTE NEUROPROTECTION SYSTEM (NPS). AS A MOST-LIKELY DEVICE COULD NOT BE DETERMINED, AN MDR IS BEING REPORTED FOR BOTH DEVICES. PLEASE SEE MDR 2124215-2025-64583, WHICH CAPTURES THE ENROUTE NPS USED DURING THIS PROCEDURE. B3: DATE OF EVENT: THE EVENT DATE WAS APPROXIMATED TO THE DATE BSC BECAME AWARE OF THE EVENT, 08/19/2025. D6A: IMPLANT DATE: THE IMPLANT DATE WAS APPROXIMATED TO THE DATE BSC BECAME AWARE OF THE EVENT, 08/19/2025. DETAILS OF THE EVENT, INCLUDING PATIENT STATUS AND PRODUCT INFORMATION, WERE NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT LOT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) NUMBER AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT HAD A STROKE POST PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED BY THE PHYSICIAN THAT SOMETIME AFTER THE PROCEDURE, THE PATIENT HAD A STROKE. AT THIS TIME, IT IS UNKNOWN WHEN THE STROKE EVENT OCCURRED OR IF ANY INTERVENTION WAS PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE TO BOSTON SCIENTIFIC.
IT WAS REPORTED THAT THE PATIENT HAD A STROKE POST PROCEDURE. AN ENROUTE TRANSCAROTID STENT WAS SELECTED FOR USE IN THE RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. IT WAS REPORTED BY THE PHYSICIAN THAT SOMETIME AFTER THE PROCEDURE, THE PATIENT HAD A STROKE. AT THIS TIME, IT IS UNKNOWN WHEN THE STROKE EVENT OCCURRED OR IF ANY INTERVENTION WAS PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE TO BOSTON SCIENTIFIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1969960 | ENROUTE TRANSCAROTID STENT | STENT, CAROTID | NIM | SILK ROAD MEDICAL | FG11815 | 0018422737 | 00811311021314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Other |