FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1910332
·
Received November 23, 2010
Report
- Report Number
- 2953161-2010-00213
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- October 22, 2010
- Report Date
- November 23, 2010
- 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
METHOD: A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADD'L DEVICES INVOLVED: (B)(4).
Description of Event or Problem · 1
ON (B)(6), 2009, THIS PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2010, A ROUTINE CT SCAN WAS TAKEN. THE CT SCAN REVEALED ANEURYSM ENLARGEMENT OF 9MM. THE CAUSE OF ENLARGEMENT WAS UNK. ON (B)(6), 2010, AN ANGIOGRAM WAS TAKEN, REVEALING A TYPE II ENDOLEAK ORIGINATING FROM A SACRAL BRANCH. THE PHYSICIAN TREATED THE TYPE II ENDOLEAK WITH COIL EMBOLIZATION. THE ENDOLEAK RESOLVED AND THE PT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES | WLG425 | 06685229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization| R |