FDA Adverse Event
Injury
Summary report: N
GORE® EXCLUDER® AAA ENDOPROSTHESIS
MDR report key: 3798793
·
Received May 8, 2014
Report
- Report Number
- 2017233-2014-00235
- Event Type
- Injury
- Date Received
- May 8, 2014
- Date of Event
- April 24, 2014
- Report Date
- July 29, 2014
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURING SITE WAS CORRECTED AND THE APPROPRIATE MANUFACTURER REPORT NUMBER 2953161. ADDITIONAL DEVICE INVOLVED IN THIS EVENT (LOT# 0420902/PXC141400).
Additional Manufacturer Narrative · 1
THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON AN UNKNOWN DATE IN 2004, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2014 THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE A TYPE I ENDOLEAK. THE PATIENT WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS COMPONENT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279391 | GORE® EXCLUDER® AAA ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 041451014A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |