FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3050584
·
Received April 10, 2013
Report
- Report Number
- 2029214-2013-00357
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- March 27, 2013
- Report Date
- March 27, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 A RIGHT UNRUPTURED OPHTHALMIC SACCULAR ANEURYSM MEASURING 7MM X 4MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PROXIMAL SECTION OF THE PIPELINE WAS FLATTENED. THE FLATTENED SECTION WAS OPENED BY PULLING THE CAPTURE COIL THROUGH THE PIPELINE.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152545 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77425-12 | 9670896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Disability |