FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3033780
·
Received April 3, 2013
Report
- Report Number
- 2029214-2013-00326
- Event Type
- Injury
- Date Received
- April 3, 2013
- Date of Event
- July 11, 2012
- Report Date
- March 13, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. THE OTHER DEVICE INVOLVED IN THE EVENT IS AS FOLLOWS: (B)(4)/ LOT: NOT REPORTED / DOM: N/A / EXP: N/A. (B)(4).
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A RIGHT UNRUPTURED ICA (INTERNAL CAROTID ARTERY) SIDEWALL ANEURYSM MEASURING 10.5MM X 9MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING TWO PIPELINES ON (B)(6) 2012 AND EXPERIENCED BLURRED VISION WITH DECREASE VISION ACUITY IN THE RIGHT EYE ON (B)(6) 2012. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136702 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77500-16 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Disability |