FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3113760
·
Received May 15, 2013
Report
- Report Number
- 2029214-2013-00463
- Event Type
- Injury
- Date Received
- May 15, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 22, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 PARAOPHTHALMIC ICA (INTERNAL CAROTID ARTERY) ANEURYSM. AFTER ADVANCING THE PIPELINE THROUGH A TORTUOUS ANATOMY, IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DEPLOY THE PIPELINE IN A PORTION OF THE ARTERY THAT WAS QUITE STRAIGHT. UPON DEPLOYMENT OF THE PIPELINE, THE DISTAL SEGMENT COULD NOT BE RELEASED FROM THE CAPTURE COIL. THE PIPELINE EVENTUALLY RELEASED FROM THE CAPTURE COIL WITH SOME MANIPULATION. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214079 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77350-12 | 9428793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |