FDA Adverse Event
Malfunction
Summary report: N
ENDURANT BIFURCATED STENT GRAFT
MDR report key: 2102885
·
Received May 4, 2011
Report
- Report Number
- 2953200-2011-00937
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION, RESULTS: (ENDOLEAK).
Description of Event or Problem · 1
AN ENDURANT BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.1 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS DESCRIBED AS STRAIGHTFORWARD WITH UNREMARKABLE CALCIFICATION AND TORTUOSITY. AFTER THE ENDURANT BIFUR WAS PLACED, A SUSPECT TYPE IV ENDOLEAK/BLUSH WAS OBSERVED AROUND THE FLOW DIVIDER. NO INTERVENTION WAS PERFORMED, AND THE PT WILL BE MONITORED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDURANT BIFURCATED STENT GRAFT | MIH | MEDTRONIC IRELAND | NA | V00826385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |