FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3073537
·
Received April 23, 2013
Report
- Report Number
- 2029214-2013-00400
- Event Type
- Injury
- Date Received
- April 23, 2013
- Date of Event
- June 1, 2011
- Report Date
- April 15, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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
INFORMATION RECEIVED FROM THE (B)(4).TREATMENT OF A LEFT UNRUPTURED SACCULAR SIDEWALL ANEURYSM MEASURING 23MM X 12MM. POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT'S VISUAL ACUITY WORSENED.IT WAS REPORTED THAT THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2011
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174397 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | NOT REPORTED | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Disability |