FDA Adverse Event
Malfunction
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3770727
·
Received April 24, 2014
Report
- Report Number
- 2029214-2014-00241
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- March 24, 2013
- Report Date
- March 28, 2014
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
TREATMENT OF A UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE SUPRACLINOID SEGMENT OF THE RIGHT ICA (INTERNAL CAROTID ARTERY). THE PATIENT WAS ON DUAL ANTI-PLATELET THERAPY. ON (B)(6) 2013, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE COULD NOT BE RELEASED FROM THE CAPTURE COIL AND IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE TIME WAS EXTENDED FOR 20 MINUTES. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248736 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77450-14 | 9775525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |