Brand Name | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM |
Type of Device | SELF EXPANDING STENT SYSTEM |
Manufacturer (Section D) |
AV-TEMECULA-CT |
abbott vascular |
26531 ynez road |
temecula CA 92591 4628 |
|
Manufacturer (Section G) |
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168 |
abbott vascular |
26531 ynez road |
temecula CA 92591 4628 |
|
Manufacturer Contact |
connie
speck
|
abbott vascular |
26531 ynez road |
temecula, CA 92591-4628
|
9519143996
|
|
MDR Report Key | 8264241 |
MDR Text Key | 133794823 |
Report Number | 2024168-2019-00466 |
Device Sequence Number | 1 |
Product Code |
NIO
|
UDI-Device Identifier | 08717648175633 |
UDI-Public | 08717648175633 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | P110028 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Physician
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
01/21/2019 |
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 | 09/30/2019 |
Device Catalogue Number | 1012529-60 |
Device Lot Number | 6102861 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/12/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/16/2019
|
Initial Date FDA Received | 01/21/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/01/2016 |
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 |