FDA Adverse Event
Malfunction
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2972262
·
Received February 21, 2013
Report
- Report Number
- 2029214-2013-00149
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 28, 2013
- Report Date
- January 28, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PIPELINE, PUSHWIRE, AND MARKSMAN CATHETER HAVE BEEN RETURNED FOR EVALUATION. THE PUSHWIRE WAS EVALUATED AND THE CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THE CAPTURE COIL WAS FOUND DAMAGE WHICH MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE.(B)(4).
Description of Event or Problem · 1
TREATMENT OF A LEFT UNRUPTURED PETROUS PARACLINOID ANEURYSM MEASURING 7.50MM X 6.20MM. DURING PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PIPELINE WOULD NOT RELEASE FROM THE CAPTURE COIL AND 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 |
|---|---|---|---|---|---|---|---|
| 76630 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77400-16 | 9657153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |