FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2501238
·
Received March 23, 2012
Report
- Report Number
- 2029214-2012-00178
- Event Type
- Injury
- Date Received
- March 23, 2012
- Date of Event
- November 29, 2011
- Report Date
- November 29, 2011
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 PIPELINE INVOLVED: MODEL: FA-71500-25 / LOT: 9517206 - DOM: 11/18/2011 - EXP: 8/1/2014. (B)(4).
Description of Event or Problem · 1
TREATMENT OF AN ANEURYSM. IT WAS REPORTED THE PIPELINE WAS TWISTED DURING DEPLOYMENT. THE ISSUE WAS RESOLVED BY MANIPULATION THE DEVICE AND A BALLOON WAS USED. 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-71500-35 | OC11-024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |