FDA Adverse Event
Injury
Summary report: N
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 2080584
·
Received April 22, 2011
Report
- Report Number
- 2953200-2011-00866
- Event Type
- Injury
- Date Received
- April 22, 2011
- Date of Event
- March 24, 2011
- Report Date
- March 24, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS & CONCLUSION: (SEVERELY TORTUOUS AND MILDLY ANGULATED ILIAC ARTERIES).
Description of Event or Problem · 1
AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. THE AORTIC NECK WAS STRAIGHT AND THE ILIAC ARTERIES WERE SEVERELY TORTUOUS WITH MILD CALCIFICATION. THERE WAS SLIGHT KINKING OF THE STENT GRAFT IN THE ILIAC ARTERIES BILATERALLY (REF MFR 2953200-2011-00865). THE PHYSICIAN ELECTED TO IMPLANT TWO PALMAZ STENTS WITHIN THE ILIAC LIMBS OF THE BIFURCATED STENT GRAFT EXTENSION AND THE CONTRALATERAL ILIAC STENT GRAFTS. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDURANT ABDOMINAL STENT GRAFT SYSTEM | MIH | MEDTRONIC IRELAND | NA | V00807925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |