FDA Adverse Event
Death
Summary report: N
ENDURANT ILIAC STENT GRAFT
MDR report key: 4943293
·
Received July 27, 2015
Report
- Report Number
- 2953200-2015-01146
- Event Type
- Death
- Date Received
- July 27, 2015
- Date of Event
- April 9, 2014
- Report Date
- April 11, 2016
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 59.7MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. PER THE INVESTIGATOR, THE DEATH WAS NOT RELATED TO THE PROCEDURE. THE DEVICE RELATION IS UNKNOWN.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT INVESTIGATOR ASSESSED THE PATIENT DEATH WAS NOT RELATED TO THE DEVICE OR PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 485806 | ENDURANT ILIAC STENT GRAFT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | ENLW1620C120EE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00089 YR | Death |