FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2770727
·
Received October 3, 2012
Report
- Report Number
- 2029214-2012-00521
- Event Type
- Injury
- Date Received
- October 3, 2012
- Date of Event
- August 17, 2012
- Report Date
- September 7, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES INVOLVED IN THE PROCEDURE WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. MODEL# AND LOT# OF OTHER PIPELINE INVOLVED: MODEL#: FA-77300-16; LOT#: 9612172; DOM: 07/05/2012; EXPIRATION: 05/10/2014. (B)(4).
Description of Event or Problem · 1
TREATMENT OF A GIANT CAVERNOUS (CAV) ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD A PARENCHYMAL LEFT FRONTAL INTRACEREBRAL HEMORRHAGE NINE HOURS POST PIPELINE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-71300-25 | SE11-018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |