FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3050457
·
Received April 10, 2013
Report
- Report Number
- 2029214-2013-00345
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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).
Description of Event or Problem · 1
TREATMENT OF A LEFT UNRUPTURED CAV (CAVERNOUS) SACCULAR ANEURYSM MEASURING 17.2MM X 6 MM. DURING THE PROCEDURE, IT WAS REPORTED THAT TWO PIPELINES REQUIRED THE J WIRE TECHNIQUE TO RELEASE THEM FROM THEIR CAPTURE COILS. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR # 2029214-2013-00346.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153511 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-71500-30 | 9652021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Disability |