D
Patient 1
AS REPORTED, IN 2003 THIS PT WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS. A FOLLOW COMPUTED TOMOGRAPHY SCAN ON AN UNK DATE REVEALED ANEURYSM SAC ENLARGEMENT. FURTHER INVESTIGATION IS BEING CONDUCTED.
MAUDE MDR 1084658
- MDR report key
- 1084658
- Report number
- 2017233-2008-00418
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-07-02
- Date received
- 2008-07-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- DANIELLE FAZIO
- Address
- 3450 WEST KILTIE LANE FLAGSTAFF AZ 86001 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | W.L. GORE & ASSOCIATES | MIH | WLG325 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-07-29 | 0 | 1. O |