FDA Adverse Event
Injury
Summary report: N
ANEURX AAADVANTAGE STENT GRAFT SYSTEM
MDR report key: 2050891
·
Received April 1, 2011
Report
- Report Number
- 2953200-2011-00744
- Event Type
- Injury
- Date Received
- April 1, 2011
- Date of Event
- January 1, 2008
- Report Date
- March 4, 2011
- Manufacturer
- MEDTRONIC CARDIOVASCULAR SANTA ROSA
- Product Code
- MIH
- PMA / PMN Number
- P990020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION RESULTS: STENT GRAFT MIGRATION, AORTIC NECK DILATATION. CONCLUSION: AORTIC NECK DILATATION.
Description of Event or Problem · 1
AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM 56 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNK. IT WAS REPORTED THAT THE STENT GRAFT MIGRATED DUE TO AORTIC NECK DILATION TO 30 MM WITH NO EVIDENCE OF AN ENDOLEAK. IT WAS ALSO NOTED THAT THE STENT GRAFT MIGRATION BEGAN IN 2008. THE DECISION WAS MADE TO PLACE AN AORTIC CUFF AT A LATER DATE. NO FURTHER INFORMATION WAS PROVIDED AND THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANEURX AAADVANTAGE STENT GRAFT SYSTEM | MIH | MEDTRONIC CARDIOVASCULAR SANTA ROSA | NA | B14952 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |