FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3050382
·
Received April 10, 2013
Report
- Report Number
- 2029214-2013-00349
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- March 20, 2013
- Report Date
- March 20, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
TREATMENT OF A RIGHT UNRUPTURED OPHTHALMIC SACCULAR ANEURYSM MEASURING 22MM X 5MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PIPELINE WOULD NOT RELEASE FROM THE CAPTURE COIL. WITH SOME MANIPULATION OF THE MARKSMAN CATHETER, THE PIPELINE RELEASED FROM THE CAPTURE COIL AND WAS IMPLANTED IN 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 |
|---|---|---|---|---|---|---|---|
| 152939 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77375-16 | 9708291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention| S |