FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2822586
·
Received November 7, 2012
Report
- Report Number
- 2029214-2012-00608
- Event Type
- Injury
- Date Received
- November 7, 2012
- Date of Event
- October 10, 2012
- Report Date
- October 10, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE PROCEDURE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).
Description of Event or Problem · 1
ONE DAY POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD A PARENCHYMAL HEMORRHAGE.FOLLOW UP ON (B)(6) 2012, BUT THE PATIENT'S CONDITION IS STILL UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77400-14 | 9614915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |