Brand Name | GORE® EXCLUDER® AAA ENDOPROSTHESIS |
Type of Device | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Manufacturer (Section D) |
W. L. GORE & ASSOCIATES, INC. |
1505 n. fourth street |
flagstaff AZ 86004 |
|
Manufacturer (Section G) |
MEDICAL PHOENIX 2 B/P |
32470 n. north valley parkway |
|
phoenix AZ 85085 |
|
Manufacturer Contact |
tom
hormby
|
1505 n. fourth street |
flagstaff, AZ 86004
|
9285263030
|
|
MDR Report Key | 13549120 |
MDR Text Key | 290275374 |
Report Number | 3007284313-2022-01779 |
Device Sequence Number | 1 |
Product Code |
MIH
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | P020004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
09/30/2022 |
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 |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/19/2022
|
Initial Date FDA Received | 02/17/2022 |
Supplement Dates Manufacturer Received | 09/30/2022
|
Supplement Dates FDA Received | 09/30/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
Patient Age | 67 YR |
Patient Sex | Female |
|
|