FDA Adverse Event
Death
Summary report: N
ANEURX AAADVANTAGE STENT GRAFT SYSTEM
MDR report key: 854938
·
Received May 24, 2007
Report
- Report Number
- 2953200-2007-00204
- Event Type
- Death
- Date Received
- May 24, 2007
- Date of Event
- May 2, 2007
- Report Date
- May 2, 2007
- Manufacturer
- MEDTRONIC VASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P990020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DEATH).
Description of Event or Problem · 1
AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM. WHILE IN THE RECOVERY ROOM, THE PATIENT HAD A MILD INJECTION FRACTION AND EXPIRED. IT WAS REPORTED TO MEDTRONIC THAT THE PHYSICIAN DOES NOT BELIEVE THE DEATH WAS DEVICE OR PROCEDURE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANEURX AAADVANTAGE STENT GRAFT SYSTEM | MIH | MEDTRONIC VASCULAR | NA | 1000044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death |