FDA Adverse Event
Death
Summary report: N
ENDURANT
MDR report key: 4933974
·
Received July 22, 2015
Report
- Report Number
- 2953200-2015-01107
- Event Type
- Death
- Date Received
- July 22, 2015
- Date of Event
- January 1, 2015
- Report Date
- June 30, 2015
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE TREATMENT OF A 5.5CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. AT THE INDEX PROCEDURE, THE PROXIMAL AORTIC NECK WAS 21-22 MM IN DIAMETER. THE DISTAL AORTA WAS 24 MM IN DIAMETER. THE RIGHT ILIAC ARTERY WAS 12 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 10.9 MM IN DIAMETER. THE RIGHT FEMORAL ARTERY WAS 9.9 MM IN DIAMETER AND THE LEFT FEMORAL ARTERY WAS 8.4 MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475453 | ENDURANT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Death |