FDA Adverse Event
Death
Summary report: N
TALENT ABDOMINAL STENT GRAFT SYSTEM T-HYDRO
MDR report key: 1230180
·
Received November 13, 2008
Report
- Report Number
- 2953200-2008-01044
- Event Type
- Death
- Date Received
- November 13, 2008
- Date of Event
- October 15, 2008
- Report Date
- October 16, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P070027
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION CODES, RESULTS: (CONCLUSION CODE: (CHOLESTEROL SHOWERING).
Description of Event or Problem · 1
A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT ONE DAY AFTER THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED, THE PT EXPERIENCED CHOLESTEROL SHOWERING. THE PT EXPIRED THE FOLLOWING DAY. NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALENT ABDOMINAL STENT GRAFT SYSTEM T-HYDRO | MIH | MEDTRONIC CARDIOVASCULAR | NA | V00180040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |