FDA Adverse Event
Death
Summary report: N
ANEURX AAADVANTAGE STENT GRAFT SYSTEM
MDR report key: 844588
·
Received May 3, 2007
Report
- Report Number
- 2953200-2007-00182
- Event Type
- Death
- Date Received
- May 3, 2007
- Date of Event
- March 27, 2007
- Report Date
- April 5, 2007
- Manufacturer
- MEDTRONIC VASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P990020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AN ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE SUCCESSFULLY IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE FINAL ANGIOGRAM REVEALED PERFECT IMPLANTATION RESULTS. THERE WERE NO ENDOLEAKS OR BLUSHING ON THE FINAL ANGIOGRAM. THE PHYSICIAN HAD CHECKED THE PATIENT THE FOLLOWING MORNING; SIGNED PAPERS THAT THE PT COULD BE DISCHARGED FROM THE HOSPITAL. HOWEVER, LATER THAT MORNING, THE PT BLED OUT AND EXPIRED. THE FAMILY REFUSED TO HAVE AN AUTOPSY AND THE CAUSE OF THE BLEEDING IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANEURX AAADVANTAGE STENT GRAFT SYSTEM | MIH | MIH | MEDTRONIC VASCULAR | NA | 1000335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Death |