FDA Adverse Event
Death
Summary report: N
ENDURANT
MDR report key: 4122302
·
Received September 26, 2014
Report
- Report Number
- 2953200-2014-01942
- Event Type
- Death
- Date Received
- September 26, 2014
- Date of Event
- September 1, 2010
- Report Date
- April 23, 2015
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. THE INVESTIGATOR REPORTED THE CAUSE OF DEATH WAS NOT DEVICE OR PROCEDURE RELATED. THERE IS NO FURTHER INFORMATION AVAILABLE.
Description of Event or Problem · 1
AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE INVESTIGATOR REPORTED THAT THE PATIENT EXPIRED HOWEVER THE CAUSE WAS NOT REPORTED. THERE IS NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600876 | ENDURANT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V00532531 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Death |