FDA Adverse Event
Death
Summary report: N
TALENT THORACIC STENT GRAFT SYSTEM
MDR report key: 2010475
·
Received March 3, 2011
Report
- Report Number
- 2953200-2011-00591
- Event Type
- Death
- Date Received
- March 3, 2011
- Date of Event
- April 14, 2010
- Report Date
- February 1, 2011
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P070007
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION, RESULTS: (DEATH). EVALUATION, RESULTS/CONCLUSIONS: (LACK OF INFO).
Description of Event or Problem · 1
A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A FUSIFORM IN SHAPE MEASURING 5 CM DIAMETER THORACIC AORTIC ANEURYSM 23 MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE DIAMETER OF THE AORTA 2 CM PROXIMAL TO THE ANEURYSM WAS 34 MM, DISTALLY THE DIAMETER WAS 33 MM. THE PHYSICAL EXAM DOCUMENTED THAT THE PT HAD AN ABNORMAL SYSTOLIC EJECTION MURMUR. IT WAS REPORTED THAT THE PT HAD A CARDIAC ARREST 12 MONTHS POST STENT GRAFT IMPLANT AND EXPIRED ON THE SAME DAY. THE INVESTIGATOR'S ASSESSMENT IS IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP TO THE DEVICE, PROCEDURE AND THE ANEURYSM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALENT THORACIC STENT GRAFT SYSTEM | MIH | MEDTRONIC CARDIOVASCULAR | NA | V00232735 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death |