Brand Name | SUPERA 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 462 |
|
Manufacturer (Section G) |
WEBSTER, TX USA REG#3005325609 |
abbott vascular |
26531 ynez rd. |
temecula CA 92591 462 |
|
Manufacturer Contact |
connie
speck
|
abbott vascular |
26531 ynez rd. |
temecula, CA 92591-4628
|
9519143996
|
|
MDR Report Key | 4326481 |
MDR Text Key | 5252529 |
Report Number | 2024168-2014-08149 |
Device Sequence Number | 1 |
Product Code |
NIP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P120020 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Health Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
11/18/2014 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2015 |
Device Catalogue Number | S-05-080-120-6F |
Device Lot Number | 02036059 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/18/2014
|
Initial Date FDA Received | 12/12/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/01/2013 |
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 |
Patient Outcome(s) |
Required Intervention;
Disability;
|
Patient Age | 78 YR |
Patient Weight | 86 |