FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2801434
·
Received October 11, 2012
Report
- Report Number
- 2017233-2012-00706
- Event Type
- Injury
- Date Received
- October 11, 2012
- Date of Event
- September 17, 2012
- Report Date
- September 14, 2012
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
ON (B)(6) 2012, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A COMPUTED TOMOGRAPHY SCAN (CT) REVEALED POSSIBLE PROXIMAL TYPE I OR TYPE II ENDOLEAK. ON (B)(6) 2012, THE PHYSICIAN REINTERVENED AND IMPLANTED A GORE AORTIC EXTENDER COMPONENT AND RESOLVED THE PROXIMAL TYPE I ENDOLEAK. AN ANGIOGRAPHY REVEALED THERE WAS ALSO A TYPE II ENDOLEAK PRESENT, WITH MULTIPLE COLLATERAL VESSELS. THE PHYSICIAN CHOSE TO NOT INTERVENE AT THIS TIME. 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 | 10275583 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| R | PXA280300/7612587| PXA280300/8526393| RMT281416/10153406| PXC201200/8561481 |