FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3231895
·
Received December 6, 2012
Report
- Report Number
- 2029214-2012-00681
- Event Type
- Injury
- Date Received
- December 6, 2012
- Date of Event
- November 6, 2012
- Report Date
- November 6, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PT AND THE PUSHER WAS DISCARDED. (B)(4).
Description of Event or Problem · 1
DURING THE PROCEDURE, IT WAS REPORTED THAT THE PIPELINE WAS IMPLANTED IN THE OPHTHALMIC SEGMENT OF THE INTERIOR CAROTID ARTERY (ICA) WITH NO COMPLICATIONS, BUT IT HAD MIGRATED TO THE ICA TERMINUS SEVERAL HOURS POST OPERATION. IT WAS REPORTED THAT THE PT WAS SUFFERING FROM STROKE-LIKE SYMPTOMS, BUT WAS FEELING BETTER AS OF (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77400-12 | 9652020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Disability |