Brand Name | PIPELINE FLEX |
Type of Device | INTRACRANIAL ANEURYSM FLOW DIVERTER |
Manufacturer (Section D) |
MICRO THERAPEUTICS, INC. DBA EV3 |
9775 toledo way |
irvine CA 92618 |
|
Manufacturer (Section G) |
MICRO THERAPEUTICS, INC. DBA EV3 |
9775 toledo way |
|
irvine CA 92618 |
|
Manufacturer Contact |
glen
belmer
|
9775 toledo way |
irvine, CA 92618
|
6122713209
|
|
MDR Report Key | 12526282 |
MDR Text Key | 273149362 |
Report Number | 2029214-2021-01195 |
Device Sequence Number | 1 |
Product Code |
OUT
|
UDI-Device Identifier | 00847536016835 |
UDI-Public | 00847536016835 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | P100018.S033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
Report Date |
12/22/2021 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 09/24/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | PED-475-35 |
Device Catalogue Number | PED-475-35 |
Device Lot Number | B078298 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/21/2021 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/17/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/29/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|