FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3232823
·
Received July 18, 2013
Report
- Report Number
- 2029214-2013-00628
- Event Type
- Injury
- Date Received
- July 18, 2013
- Date of Event
- June 26, 2013
- Report Date
- June 26, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- 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(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
TREATMENT OF A LEFT CAROTID TERMINUS ANEURYSM MEASURING 6MM X 6MM IN SIZE. DURING THE PIPELINE PROCEDURE, IT WAS REPORTED THAT ALL THREE PIPELINE DEVICES REQUIRED BALLOON ANGIOPLASTY TO ACHIEVE FULL WALL APPOSITION (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE).NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2013-00627 AND 2029214-2013-00629.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334157 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77400-18 | 9714558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |