FDA Adverse Event
Malfunction
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3182096
·
Received June 21, 2013
Report
- Report Number
- 2029214-2013-00561
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 28, 2013
- Report Date
- May 28, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).
Additional Manufacturer Narrative · 1
THE PIPELINE WAS RETURNED FOR EVALUATION WITHOUT THE PUSHWIRE AND CATHETER. THE PIPELINE WAS FOUND FULLY OPENED; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED.(B)(4).
Description of Event or Problem · 1
TREATMENT OF A RIGHT INTERNAL CAROTID C4 SACCULAR ANEURYSM MEASURING 22MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PIPELINE WOULD NOT FULLY OPEN AFTER IT WAS RELEASED FROM THE CAPTURE COIL. 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 |
|---|---|---|---|---|---|---|---|
| 281850 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77450-20 | 9712074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |