Brand Name | ENROUTE TRANSCAROTID STENT SYSTEM |
Type of Device | TSS |
Manufacturer (Section D) |
SILK ROAD MEDICAL INC. |
1213 innsbruck drive |
sunnyvale CA 94089 |
|
Manufacturer (Section G) |
SILK ROAD MEDICAL INC. |
1213 innsbruck drive |
|
sunnyvale CA 94089 |
|
Manufacturer Contact |
magaly
boardman
|
1213 innsbruck drive |
sunnyvale, CA 94089
|
4087309002
|
|
MDR Report Key | 12196346 |
MDR Text Key | 262439817 |
Report Number | 3014526664-2021-00107 |
Device Sequence Number | 1 |
Product Code |
NIM
|
UDI-Device Identifier | 00811311020508 |
UDI-Public | (01)00811311020508(17)240229(10)18007633 |
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 |
07/20/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/20/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/29/2024 |
Device Model Number | SR-0940-CS |
Device Catalogue Number | SR-0940-CS |
Device Lot Number | 18007633 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/23/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/24/2021 |
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) |
Required Intervention;
Disability;
|
Patient Age | 80 YR |