FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2501279
·
Received March 23, 2012
Report
- Report Number
- 2029214-2012-00173
- Event Type
- Injury
- Date Received
- March 23, 2012
- Date of Event
- August 30, 2011
- Report Date
- August 30, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. MODEL# AND LOT# OF OTHER PIPELINES INVOLVED: MODEL: FA-71425-35 / LOT: 9466797 - DOM: 7/18/2011 - EXP: 5/1/2014, MODEL: FA-71450-35 / LOT: 9466809 - DOM: 7/18/2011 - EXP: 5/1/2014, MODEL: FA-71450-30 / LOT: 9466943 - DOM: 7/18/2011 - EXP: 5/1/2014. (B)(4).
Description of Event or Problem · 1
TREATMENT OF AN ANEURYSM. IT WAS REPORTED THE PIPELINES WERE FLATTENED AND TWISTED DURING DEPLOYMENT. THE ISSUE WAS RESOLVED BY MANIPULATION THE DEVICE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-71375-35 | 9466843 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |