Brand Name | PIPELINE FLEX W/SHIELD TECHNOLOGY |
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 | 13712808 |
MDR Text Key | 286961322 |
Report Number | 2029214-2022-00377 |
Device Sequence Number | 1 |
Product Code |
OUT
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | P100018 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/09/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/29/2023 |
Device Model Number | PED2-500-25 |
Device Catalogue Number | PED2-500-25 |
Device Lot Number | B047535 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/02/2022 |
Initial Date FDA Received | 03/09/2022 |
Date Device Manufactured | 06/29/2020 |
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 |