FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1935340
·
Received December 15, 2010
Report
- Report Number
- 2017233-2010-00554
- Event Type
- Injury
- Date Received
- December 15, 2010
- Date of Event
- October 4, 2010
- Report Date
- December 13, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6), 2010, THIS PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2010, THIS PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN. A CT SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6), 2010, AN ANGIOGRAM CONFIRMED THE PROXIMAL TYPE I ENDOLEAK. ON (B)(6), 2010, AN AORTIC EXTENDER COMPONENT AND A PALMAZ STENT WERE IMPLANTED TO ADDRESS THE TYPE I ENDOLEAK. THE ENDOLEAK RESOLVED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | NONE | MIH | W.L. GORE & ASSOCIATES | WLG425 | 7188491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | ASPIRIN| BETABLOCKER| GLAUCOMA MEDICINE| ANXIETY PILLS |