FDA Adverse Event
Malfunction
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3050412
·
Received April 10, 2013
Report
- Report Number
- 2029214-2013-00350
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 25, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
TREATMENT OF A RIGHT RUPTURED SUPRACLINOID SACCULAR ANEURYSM MEASURING 20MM X 6MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE MIDDLE SECTION OF THE PIPELINE DID NOT FULLY OPEN AS IT WAS DEPLOYED ALONG A BEND. AFTER FAILED ATTEMPTS OF MANIPULATING THE PUSHWIRE IN ORDER TO FULLY OPEN THE MIDDLE SECTION OF THE PIPELINE, IT WAS CORKED AND 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 |
|---|---|---|---|---|---|---|---|
| 152015 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77400-18 | 9626038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |