FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3073458
·
Received April 23, 2013
Report
- Report Number
- 2029214-2013-00394
- Event Type
- Injury
- Date Received
- April 23, 2013
- Date of Event
- April 9, 2013
- Report Date
- April 9, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 A LEFT UNRUPTURED PETROUS SACCULAR ANEURYSM MEASURING 20MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PIPELINE TWISTED AND A BALLOON COULD NOT BE ADVANCED THROUGH IT. THE PIPELINE REMAINS IN THE PATIENT STILL INCOMPLETELY OPEN. A GROIN COMPLICATION OCCURRED AND THE PSEUDO ANEURYSM HAD TO BE COILED.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174995 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-71500-35 | 9636958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Disability |