FDA Adverse Event
Death
Summary report: N
TALENT THORACIC STENT GRAFT SYSTEM
MDR report key: 1695089
·
Received May 18, 2010
Report
- Report Number
- 2953200-2010-00857
- Event Type
- Death
- Date Received
- May 18, 2010
- Date of Event
- January 9, 2010
- Report Date
- April 19, 2010
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P070007
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4): EVAL, RESULTS: LACK OF INFO (CAUSE OF DEATH IS UNK). (DEATH).
Description of Event or Problem · 1
A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE PT EXPIRED AT HOME 60 MONTHS POST IMPLANT. THE CAUSE OF DEATH IS UNK, AND NO ADDITIONAL INFO WAS PROVIDED. THE RELATIONSHIPS TO THE DEVICE AND TO THE PROCEDURE HAVE NOT BEEN ASSESSED. (MFR # 2953200-2010-00858, MFR# 2953200-2010-00859).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALENT THORACIC STENT GRAFT SYSTEM | MIH | MEDTRONIC CARDIOVASCULAR | NA | M03H901459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |