FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3050535
·
Received April 10, 2013
Report
- Report Number
- 2029214-2013-00355
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- March 26, 2013
- Report Date
- March 26, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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 AN OPHTHALMIC ANEURYSM MEASURING 6MM X 5.50MM. DURING THE PIPELINE PROCEDURE INVOLVING TWO PIPELINES, IT WAS REPORTED THAT THE FIRST PIPELINE WAS FLATTENED AROUND A TIGHT BEND AND COULD NOT BE RELEASED FROM THE CAPTURE COIL DESPITE BEING WAGGED. IT WAS CORKED AND REMOVED FROM THE PATIENT. A SECOND PIPELINE WAS IMPLANTED SUCCESSFULLY WITH THE HELP OF BALLOON ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE) ON THE PROXIMAL END TO ACHIEVE FULL WALL APPOSITION. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2013-00354.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154016 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77400-12 | 9652020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |