FDA Adverse Event
Injury
Summary report: N
TALENT ABDOMINAL STENT GRAFT SYSTEM
MDR report key: 2900511
·
Received January 7, 2013
Report
- Report Number
- 2953200-2013-00033
- Event Type
- Injury
- Date Received
- January 7, 2013
- Date of Event
- November 25, 2012
- Report Date
- December 10, 2012
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; DISEASE PROGRESSION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; DISEASE PROGRESSION).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ENDURANT II (B)(4) AORTIC CUFF WAS SUCCESSFULLY IMPLANTED PROXIMAL TO THE BIFURCATED STENT GRAFT AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. AN ENDURANT (B)(4) LIMB WAS SUCCESSFULLY IMPLANTED TO TREAT THE RIGHT ILIAC LIMB, (B)(4), WERE THERE WAS ILIAC EXPANSION DUE TO DISEASE PROGRESSION. REFERENCE MFR # 2953200-2012-02082.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7686 | TALENT ABDOMINAL STENT GRAFT SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V00511258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | Required Intervention |