Brand Name | PIPELINE |
Type of Device | INTRACRANIAL ANEURYSM FLOW DIVERTER |
Manufacturer (Section D) |
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR |
9775 toledo way |
irvine CA 92618 |
|
MDR Report Key | 5056446 |
MDR Text Key | 25006649 |
Report Number | 5056446 |
Device Sequence Number | 1 |
Product Code |
OUT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Report Date |
07/31/2015 |
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 |
Physician
|
Device Expiration Date | 03/14/2018 |
Device Catalogue Number | PED-500-25 |
Device Lot Number | A073847 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/31/2015 |
Event Location |
Hospital
|
Date Report to Manufacturer | 07/31/2015 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/04/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 62 YR |
|
|