FDA Adverse Event
Injury
Summary report: N
TALENT ABDOMINAL STENT GRAFT SYSTEM HYDRO
MDR report key: 1211079
·
Received October 24, 2008
Report
- Report Number
- 2953200-2008-00968
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- September 29, 2008
- Report Date
- September 29, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P070027
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS: (PENDING DEVICE RETURNED FOR EVALUATION).
Description of Event or Problem · 1
A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. THE VESSELS WERE SEVERLY DISEASED AND FRAIL. THE PHYSICIAN BELIEVES THAT THE EVENT WAS NOT RELATED TO THE STENT GRAFT. IT WAS REPORTED THAT SIX HOURS POST STENT GRAFT PLACEMENT THE AORTA PERFORATED PROXIMAL TO THE STENT GRAFT. THE PHYSICIAN STATED THAT THE PERFORATED VESSEL WAS DUE TO THE PATIENT'S DISEASED AND FRAIL AORTA. THE PHYSICIAN ELECTED TO SURGICALLY CONVERT THE PATIENT TO A CONVENTIONAL STENT. THE EXPLANTED STENT GRAFT IS PENDING EVALUATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALENT ABDOMINAL STENT GRAFT SYSTEM HYDRO | MIH | MEDTRONIC CARDIOVASCULAR | NA | V00168516 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |