FDA Adverse Event
Death
Summary report: N
TALENT ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 1192603
·
Received October 8, 2008
Report
- Report Number
- 2953200-2008-00906
- Event Type
- Death
- Date Received
- October 8, 2008
- Report Date
- September 11, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P070027
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL RESULTS: DEATH.
Description of Event or Problem · 1
A TALENT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE PT HAD DONE WELL POST IMPLANT AND WAS SENT HOME; HOWEVER, THE PT EXPIRED AT HOME WITHIN 30 DAYS FROM THE DATE OF IMPLANT. THE EXACT DATE OF DEATH IS UNK AND THE CAUSE OF DEATH IS UNK. THE PHYSICIAN CONFIRMED THAT THE CAUSE OF THE DEATH WAS NOT ANEURYSM OR DEVICE RELATED. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALENT ABDOMINAL STENT GRAFT SYSTEM | MIH | MEDTRONIC CARDIOVASCULAR | NA | V00117647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Death |