MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-07 for ENROUTE TRANSCAROTID STENT SYSTEM SR-0940-CS manufactured by Silk Road Medical, Inc..
[179309188]
The product in complaint was not returned to the manufacturer for analysis. A review of the manufacturing records for this device was completed and no issues were identified that could have lead to the adverse event reported. Complaints will continue to be monitored for any trends.
Patient Sequence No: 1, Text Type: N, H10
[179309189]
It was reported that a patient underwent a transcarotid (tcar) procedure on (b)(6) 2020. After placement of the stent, three views and arteriograms were taken. The first view showed that the focal lesion at the ostium of the internal carotid artery (ica) was opened to about 70% patency. The second view showed similar results. The third view showed patency of under 50%. The physician indicated that he did not want to post dilate. The patient was awake and neuro intact during the entire case and as he left the room. Approximately five hours later, the physician contacted a silk road therapy development specialist indicating that the patient had suffered a stroke. The physician also indicated that the stent had recoiled and a thrombus had formed. A neuro interventionalist was called to remove the clot. No additional details have been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00005 |
| MDR Report Key | 9684790 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1213 INNSBRUCK DR. |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer G1 | SILK ROAD MEDICAL, INC. |
| Manufacturer Street | 1213 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94089 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENROUTE TRANSCAROTID STENT SYSTEM |
| Generic Name | ENROUTE SDS |
| Product Code | NIM |
| Date Received | 2020-02-07 |
| Model Number | SR-0940-CS |
| Catalog Number | SR-0940-CS |
| Lot Number | 300450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SILK ROAD MEDICAL, INC. |
| Manufacturer Address | 1213 INNSBRUCK DR. SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention; 3. Deathisabilit | 2020-02-07 |