FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3140626
·
Received May 31, 2013
Report
- Report Number
- 2029214-2013-00525
- Event Type
- Injury
- Date Received
- May 31, 2013
- Date of Event
- May 13, 2013
- Report Date
- May 13, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 AND THE PUSHWIRE WAS DISCARDED. (B)(4).
Description of Event or Problem · 1
TREATMENT OF AN MCA (MIDDLE CEREBRAL ARTERY) SIDEWALL ANEURYSM MEASURING 20MM X 26MM X 18MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE FIRST PIPELINE SLID BACK PROXIMALLY INTO THE ANEURYSM WHILE THE PHYSICIAN WAS TRYING TO GAIN ACCESS FOR THE SECOND PIPELINE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241315 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77275-16 | 9653852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Disability |