FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3033807
·
Received April 3, 2013
Report
- Report Number
- 2029214-2013-00331
- Event Type
- Injury
- Date Received
- April 3, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 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).
Description of Event or Problem · 1
TREATMENT OF A RIGHT UNRUPTURED CAV (CAVERNOUS) SACCULAR ANEURYSM MEASURING 13MM X 4.50MM. DURING PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PROXIMAL END OF THE PIPELINE DID NOT FULLY OPEN WHEN THE PHYSICIAN WAS WAGGING IT WITH THE RHV (ROTATING HEMOSTATIC VALVE) CLOSED. THE PIPELINE FULLY OPENED ONCE THE RHV WAS OPENED. REOPRO WAS ADMINISTERED DUE TO SPASTIC VESSELS CAUSING PLATELET AGGREGATION. AN ANGIOGRAPHY SHOWED A FLOW DEFECT IN THE PIPELINE AND STASIS NOTED ANGIOGRAPHICALLY. IT WAS REPORTED THAT THE PATIENT WAS NEUROLOGICALLY INTACT AND DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136721 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77425-20 | OC11-047 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Disability |