FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3182108
·
Received June 21, 2013
Report
- Report Number
- 2029214-2013-00571
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 5, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PUSHWIRE AND MARKSMAN CATHETER WERE RETURNED FOR EVALUATION WITHOUT THE PIPELINE; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. (B)(4).
Description of Event or Problem · 1
TREATMENT OF A LEFT UNRUPTURED CAVERNOUS SACCULAR ANEURYSM MEASURING 18MM X 9MM IN SIZE. DURING THE PROCEDURE, IT WAS REPORTED THAT TWO PIPELINES REQUIRED MANIPULATION TO OPEN PROXIMALLY. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2013-00570.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281873 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-71500-35 | 9663792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Disability |