FDA Adverse Event
Injury
Summary report: N
MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)
MDR report key: 1192570
·
Received October 8, 2008
Report
- Report Number
- 2953200-2008-00907
- Event Type
- Injury
- Date Received
- October 8, 2008
- Date of Event
- September 16, 2008
- Report Date
- September 16, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P990020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULTS AND CONCLUSION: LACK OF INFO (THE EXPLANTED STENT GRAFT WAS NOT RETURNED FOR EVALUATION, NO OPERATIVE REPORTS WERE RECEIVED).
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 9 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE STENT GRAFT MIGRATED AND THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFT WITHOUT ATTEMPTING TO REPAIR WITH AORTIC CUFFS. THE CAUSE OF THE MIGRATION WAS NOT REPORTED AND IT IS UNKNOWN WHETHER THE PATIENT RETURNED FOR FOLLOW-UP VISITS. THE EXPLANTED STENT GRAFT WAS NOT RETURNED TO MEDTRONIC. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) | MIH | MEDTRONIC CARDIOVASCULAR | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |