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 2019-11-25 for ENROUTE TRANSCAROTID STENT SYSTEM SR-1040-CS manufactured by Silk Road Medical, Inc..
| Report Number | 3014526664-2019-00081 |
| MDR Report Key | 9373400 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-10-29 |
| Date Mfgr Received | 2019-10-30 |
| Device Manufacturer Date | 2019-04-23 |
| Date Added to Maude | 2019-11-25 |
| 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 | 2019-11-25 |
| Model Number | SR-1040-CS |
| Catalog Number | SR-1040-CS |
| Lot Number | 17858027 |
| 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. Death; 2. Required No Informationntervention | 2019-11-25 |