FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2833189
·
Received November 15, 2012
Report
- Report Number
- 2029214-2012-00643
- Event Type
- Injury
- Date Received
- November 15, 2012
- Date of Event
- October 17, 2012
- Report Date
- October 17, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION. THE PIPELINE WAS FOUND TO BE DAMAGED WITH CLOTTED BLOOD AT ONE END WHICH LIKELY PREVENTED THE DEVICE FROM FULLY OPENING.(B)(4).
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).
Description of Event or Problem · 1
TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT THE PIPELINE DID NOT OPEN PROXIMALLY AFTER DEPLOYMENT AND A SNARE WAS USED TO REMOVE THE DEVICE FROM THE PATIENT.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77500-14 | 9643512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |