FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2894006
·
Received December 19, 2012
Report
- Report Number
- 2017233-2012-00855
- Event Type
- Injury
- Date Received
- December 19, 2012
- Date of Event
- November 20, 2012
- Report Date
- November 20, 2012
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MFG RECORDS REVIEW VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2011, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2012, THE PT UNDERWENT ANOTHER PROCEDURE TO TREAT A PROXIMAL TYPE I ENDOLEAK. ANOTHER TRUNK WAS PLACED UP TO THE LEFT RENAL ARTERY, AND THE PROXIMAL END OF THE DEVICE WAS BALLOONED TWICE. THEN THREE COILS WERE PLACED INSIDE THE ANEURYSM SAC ON THE UPPER LEFT SIDE WHERE THE ENDOLEAK APPEARED TO ORIGINATE. THE PROCEDURE WAS CONCLUDED WITH A FEM-FEM BYPASS.
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 | 8579967 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| R | LIPITOR |