Brand Name | SURPASS EVOLVE 4.5MM X 20MM - CE |
Type of Device | INTRACRANIAL ANEURYSM FLOW DIVERTER |
Manufacturer (Section D) |
STRYKER NEUROVASCULAR CORK |
ida industrial estate |
model farm road |
cork NA |
EI
NA |
|
Manufacturer (Section G) |
STRYKER NEUROVASCULAR CORK |
ida industrial estate |
model farm road |
cork NA |
EI
NA
|
|
Manufacturer Contact |
tara
lopez
|
47900 bayside parkway |
fremont, CA 94538
|
5104132500
|
|
MDR Report Key | 11962991 |
MDR Text Key | 255323028 |
Report Number | 3008881809-2021-00231 |
Device Sequence Number | 1 |
Product Code |
OUT
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P170024/S003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
07/21/2021 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 06/08/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Catalogue Number | FD45020 |
Device Lot Number | 22285012 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 06/29/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/10/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|