FDA Adverse Event
Injury
Summary report: N
ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO
MDR report key: 1790062
·
Received August 6, 2010
Report
- Report Number
- 2953200-2010-01509
- Event Type
- Injury
- Date Received
- August 6, 2010
- Date of Event
- July 9, 2010
- Report Date
- July 9, 2010
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P990020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): RESULTS: (ENDOLEAK), (DISEASE PROGRESSION).
Description of Event or Problem · 1
AN ANEURX STENT GRAFT AORTIC CUFF WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 29 MONTHS AGO. THE VESSELS WERE SEVERELY TORTUOUS AND MILDLY CALCIFIED. IT WAS REPORTED THAT THERE WAS DISEASE PROGRESSION. THE PATIENT PRESENTED FOR FOLLOW-UP AND THERE WAS A TYPE 3 ENDOLEAK BETWEEN THE RIGHT ILIAC LIMB AND THE BIFURCATED STENT GRAFT (SEE MFR # 2953200-2010-01510). THE PHYSICIAN ELECTED TO PLACE A TALENT CONVERTER STENT GRAFT AND AN OCCLUDER IN THE RIGHT ILIAC ARTERY. A FEMORAL TO FEMORAL BYPASS WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO | MIH | MEDTRONIC CARDIOVASCULAR | NA | V00071177 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |