FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2142886
·
Received June 22, 2011
Report
- Report Number
- 2953161-2011-00142
- Event Type
- Injury
- Date Received
- June 22, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 21, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- 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. (OTHER): USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PT BEFORE USING THE DEVICES. SEE SCANNED PAGE.
Description of Event or Problem · 1
ON (B)(6) 2004, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON OR ABOUT (B)(6) 2011, FOLLOW UP IMAGING REVEALED ANEURYSM GROWTH, ALONG WITH A TYPE 2 ENDOLEAK.
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 | 041240501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |