D
Patient 1
IN 2005, A GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS IMPLANTED. IN 2006, ANOTHER GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS IMPLANTED. FURTHER INVESTIGATION IS PENDING.
MAUDE MDR 981438
- MDR report key
- 981438
- Report number
- 2017233-2008-00036
- Event key
- 0
- Event type
- 3
- Date of event
- 2006-03-15
- Date received
- 2008-01-16
- 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
- KINDRA BAUM
- Address
- 3450 W. 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 | ENDOVASCULAR GRAFT SYSTEM | W.L. GORE & ASSOCIATES, INC | MIH | WLG325 | PXC201200 | 03686939 | Y | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-01-16 | 0 | 1. R |
Event Narratives#
N
Patient 1
A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.