FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2822986
·
Received November 7, 2012
Report
- Report Number
- 2029214-2012-00594
- Event Type
- Injury
- Date Received
- November 7, 2012
- Date of Event
- March 31, 2012
- Report Date
- October 8, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION BECAUSE THEY WERE IMPLANTED IN THE PATIENT.THE ONE OTHER PIPELINE DEVICE INVOLVED IN THE EVENT IS:MODEL#: FA-77500-16; LOT#: NOT REPORTED; MFG DATE: N/A; EXP DATE: N/A.(B)(4).
Description of Event or Problem · 1
INFORMATION FROM (B)(6) CLINICAL DATABASE. POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC OF PROPTOSIS, OPHTHALMOPLEGIA, DECREASED SENSATION IN THE OPHTHALMIC/MAXILLARY (V1/V2) DISTRIBUTION, SWELLING OF THE RIGHT EYE, RETRO-ORBITAL PAIN, VOMITING, AND THIRD NERVE. THE ISSUES SUBSEQUENTLY RESOLVED AND NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | EMBOLIZATION DEVICE | OUT | EV3 NEUROVASCULAR | FA-77500-20 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Disability |