FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3110053
·
Received May 13, 2013
Report
- Report Number
- 2029214-2013-00450
- Event Type
- Injury
- Date Received
- May 13, 2013
- Date of Event
- April 29, 2013
- Report Date
- April 29, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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 RIGHT DISTAL PCA (POSTERIOR CEREBRAL ANEURYSM) ANEURYSM. POST PIPELINE DEPLOYMENT, THERE WAS A SLIGHT DISSECTION OF THE VESSEL AND TWO ADDITIONAL ENTERPRISE STENTS WERE PLACED IN THAT LOCATION. NO OTHER INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211236 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77325-12 | 9623333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Disability |