FDA Adverse Event
Injury
Summary report: N
ANEURX ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 3011685
·
Received March 19, 2013
Report
- Report Number
- 2953200-2013-00488
- Event Type
- Injury
- Date Received
- March 19, 2013
- Date of Event
- February 21, 2013
- Report Date
- May 30, 2013
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P990020
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: STENT GRAFT MIGRATION, ENDOLEAK. UNKNOWN CAUSE OF STENT GRAFT MIGRATION. CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF STENT GRAFT MIGRATION).
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 APPROXIMATELY 12 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD A SECONDARY INTERVENTION APPROXIMATELY THREE WEEKS AGO DUE TO MIGRATION OF THE STENT GRAFT WITH A TYPE I ENDOLEAK. NO FURTHER INFORMATION WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113179 | ANEURX ABDOMINAL STENT GRAFT SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC CARDIOVASCULAR | M01A750557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR | Required Intervention |