Brand Name | STENTS ADVANTA V12 |
Type of Device | STENT, ILIAC |
Manufacturer (Section D) |
ATRIUM MEDICAL CORPORATION |
40 continental blvd |
merrimack NH |
|
Manufacturer (Section G) |
ATRIUM MEDICAL CORPORATION |
40 continental blvd |
|
merrimack NH |
|
Manufacturer Contact |
lori
gosselin
|
40 continental blvd |
merrimack, NH
|
|
MDR Report Key | 14754002 |
MDR Text Key | 296142724 |
Report Number | 3011175548-2022-00173 |
Device Sequence Number | 1 |
Product Code |
NIO
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
09/27/2022 |
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 Model Number | 85365 |
Device Catalogue Number | 85365 |
Device Lot Number | 476260 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/10/2022
|
Initial Date FDA Received | 06/21/2022 |
Supplement Dates Manufacturer Received | 08/02/2022 07/08/2022 09/15/2022
|
Supplement Dates FDA Received | 08/02/2022 08/23/2022 09/27/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | COOK ZENITH BRANCH ENDOVASCULAR GRAFT.; UNKNOWN. |
Patient Age | 75 YR |
Patient Sex | Male |
Patient Weight | 90 KG |