Brand Name | ENROUTE TRANSCAROTID STENT SYSTEM |
Type of Device | ENROUTE SDS |
Manufacturer (Section D) |
SILK ROAD MEDICAL, INC. |
1213 innsbruck dr. |
sunnyvale CA 94089 |
|
Manufacturer (Section G) |
SILK ROAD MEDICAL, INC. |
1213 innsbruck drive |
|
sunnyvale CA 94089 |
|
Manufacturer Contact |
|
1213 innsbruck dr. |
sunnyvale, CA 94089
|
|
MDR Report Key | 9373400 |
MDR Text Key | 167951782 |
Report Number | 3014526664-2019-00081 |
Device Sequence Number | 1 |
Product Code |
NIM
|
UDI-Device Identifier | 00811311020539 |
UDI-Public | (01)00811311020539(17)210331(10)17858027 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P140026 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/25/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/31/2021 |
Device Model Number | SR-1040-CS |
Device Catalogue Number | SR-1040-CS |
Device Lot Number | 17858027 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/30/2019 |
Initial Date FDA Received | 11/25/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/23/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
Required Intervention;
|
Patient Age | 75 YR |