FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2744128
·
Received September 13, 2012
Report
- Report Number
- 2029214-2012-00477
- Event Type
- Injury
- Date Received
- September 13, 2012
- Date of Event
- April 10, 2012
- Report Date
- August 16, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. MODEL # OF OTHER INVOLVED PIPELINES: FA-71425-25 ( 2 EA). (B)(4).
Description of Event or Problem · 1
TREATMENT OF A RIGHT CAVERNOUS ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THREE PIPELINES. 15 DAYS POST PROCEDURE, THE PATIENT HAS INTRACRANIAL HEMORRHAGE. ON (B)(6) 2012, CT SCAN WAS PERFORMED AND NO NEW BLEED WAS FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-71425-35 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |