FDA Adverse Event
Injury
Summary report: N
ENDURANT
MDR report key: 4200482
·
Received October 24, 2014
Report
- Report Number
- 2953200-2014-02182
- Event Type
- Injury
- Date Received
- October 24, 2014
- Date of Event
- October 19, 2014
- Report Date
- September 30, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT DURING FOLLOW UP, THE PHYSICIAN IDENTIFIED A LIMB OCCLUSION. PATIENT WAS TREATED AND A FEM-FEM BYPASS WAS PERFORMED SUCCESSFULLY. THE CAUSE FOR THE LIMB OCCLUSION WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678979 | ENDURANT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |