FDA Adverse Event
Malfunction
Summary report: N
ANEURX
MDR report key: 3903140
·
Received June 30, 2014
Report
- Report Number
- 2953200-2014-01316
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- June 1, 2014
- Report Date
- June 11, 2014
- Manufacturer
- MEDTRONIC CARDIOVASCULAR SANTA ROSA
- Product Code
- MIH
- PMA / PMN Number
- P990020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPH OLOGY WAS NOT REPORTED. IT WAS REPORTED THAT THE ANEURYSM IS CURRENTLY 3.6 CM IN DIAMETER. THE PATIENT PRESENTED AT A ROUTINE FOLLOW UP APPOINTMENT. IT WAS REPORTED THAT A RECENT CT REVEALED THAT THERE IS A TYPE III ENDOLEAK, FABRIC (OR SUTURE HOLE) AT THE FLOW DIVIDER OF THE BIFURCATED STENT GRAFT. THE PHYSICIANS WILL CONTINUE TO MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379953 | ANEURX | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC CARDIOVASCULAR SANTA ROSA | V00200534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR |