FDA Adverse Event
Malfunction
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3070811
·
Received April 22, 2013
Report
- Report Number
- 2029214-2013-00382
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- March 26, 2013
- Report Date
- March 27, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).
Description of Event or Problem · 1
TREATMENT OF A CAROTID OPHTHALMIC ANEURYSM THAT WAS PREVIOUSLY TREATED IN 2012 WITH A PIPELINE. DURING THE DEPLOYMENT OF THE NEW PIPELINE, IT WAS REPORTED THAT THE PIPELINE COULD NOT BE RELEASED FROM THE CAPTURE COIL AND THE TIP OF THE PUSHWIRE FRACTURED IN THE PROCESS. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171216 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77425-20 | 9559702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |