FDA Adverse Event
Injury
Summary report: N
TALENT THORACIC STENT GRAFT SYSTEM
MDR report key: 2191212
·
Received July 29, 2011
Report
- Report Number
- 2953200-2011-01363
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 30, 2011
- Manufacturer
- MEDTRONIC CARDIOVASCULAR IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P070007
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL, RESULTS: (ENDOLEAK; REMOVAL OF IMPLANT). RESULTS AND CONCLUSIONS: (DEVICE ANALYSIS IS PENDING).
Description of Event or Problem · 1
A TALENT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSM ON AN UNK DATE. IT WAS REPORTED THAT THE STENT GRAFT WAS EXPLANTED DUE TO A DISTAL TYPE I ENDOLEAK. NO FURTHER INFO LEADING TO THE EXPLANT OR CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALENT THORACIC STENT GRAFT SYSTEM | MIH | MEDTRONIC CARDIOVASCULAR IRELAND | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |