FDA Adverse Event
Malfunction
Summary report: N
TALENT AAA
MDR report key: 4140155
·
Received October 3, 2014
Report
- Report Number
- 2953200-2014-01994
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Report Date
- September 9, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P070027
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE STENT GRAFT WAS LEAKING AND THE ANEURYSM WAS 4 CM IN DIAMETER. THE PATIENT IS BEING MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 619976 | TALENT AAA | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V00423368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR |