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 SILICON VALLEY B/P |
2890 de la cruz blvd. |
|
santa clara CA 95050 |
|
Manufacturer Contact |
breanna
cox
|
1505 n. fourth street |
flagstaff, AZ 86004
|
9285263030
|
|
MDR Report Key | 13114616 |
MDR Text Key | 287792747 |
Report Number | 3013164176-2021-01283 |
Device Sequence Number | 1 |
Product Code |
MIH
|
UDI-Device Identifier | 00733132618644 |
UDI-Public | 00733132618644 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P020004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/29/2021 |
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
|
Device Expiration Date | 08/21/2023 |
Device Model Number | PLC121400 |
Device Catalogue Number | PLC121400 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/22/2021
|
Initial Date FDA Received | 12/29/2021 |
Supplement Dates Manufacturer Received | 12/22/2021
|
Supplement Dates FDA Received | 12/29/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/21/2020 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
Hospitalization;
|
Patient Age | 71 YR |
Patient Sex | Male |