FDA Adverse Event
Injury
Summary report: N
ENDURANT II ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 3031648
·
Received April 2, 2013
Report
- Report Number
- 2953200-2013-00599
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 8, 2013
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: ARTERIAL OCCLUSION. SHORT AORTIC NECK. CONCLUSION: SHORT AORTIC NECK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S AORTIC NECK MEASURED LESS THAN 10 MM IN LENGTH AND THE OTHER SIDE DID NOT HAVE VERY MUCH PURCHASE. THEREFORE THE PHYSICIAN ELECTED TO COMPROMISE THE RENAL ARTERY. TWO ENDURANT AORTIC CUFFS WERE IMPLANTED AND THERE WAS 50% ENCROACHMENT ON THE LEFT RENAL ARTERY; HOWEVER, THERE WAS GOOD BLOOD FLOW THROUGH THE RENAL ARTERY UPON COMPLETION OF THE PROCEDURE. THE PROXIMAL TYPE I ENDOLEAK WAS SUCCESSFULLY RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134354 | ENDURANT II ABDOMINAL STENT GRAFT SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V01727354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR |