FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2972599
·
Received February 21, 2013
Report
- Report Number
- 2029214-2013-00127
- Event Type
- Injury
- Date Received
- February 21, 2013
- Date of Event
- January 29, 2013
- Report Date
- January 29, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 PATIENT.(B)(4).
Description of Event or Problem · 1
TREATMENT OF A LEFT ICA (INTERNAL CAROTID ARTERY) ANEURYSM. DURING PIPELINE DEPLOYMENT, IT WAS REPORTED THAT ANGIOPLASTY WITH A HYPERFORM BALLOON (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE) WAS DONE TO ACHIEVE FULL WALL APPOSITION.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76014 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-71425-35 | JA12-033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |