FDA Adverse Event
Injury
Summary report: N
ANEURX
MDR report key: 1994061
·
Received February 16, 2011
Report
- Report Number
- 2031527-2011-00008
- Event Type
- Injury
- Date Received
- February 16, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 26, 2011
- Manufacturer
- MEDTRONIC INC.
- Product Code
- MIH
- PMA / PMN Number
- P990020
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXPIRATION AND IMPLANT DATE UNKNOWN (COMPETITOR DEVICE). DEVICE MANUFACTURE DATE UNKNOWN (COMPETITOR DEVICE). ANEURX DEVICE IS NOT MANUFACTURED BY ENDOLOGIX.
Description of Event or Problem · 1
THE PATIENT PREVIOUSLY RECEIVED AN IMPLANT OF A MEDTRONIC ANEURX DEVICE AND A MEDTRONIC PROXIMAL EXTENSION (DATE UNKNOWN). FOLLOW UP REVEALED THAT THE BIFURCATED DEVICE HAD MIGRATED DISTALLY AND THE PATIENT HAD DEVELOPED A TYPE III ENDOLEAK. ON (B)(6) 2011, THE PATIENT WAS TREATED WITH TWO 28MM AORTIC EXTENSIONS WHICH RESOLVED THE ENDOLEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANEURX | ANEURX AAADVANTAGE STENT GRAFT | MIH | MEDTRONIC INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |