FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3231897
·
Received December 6, 2012
Report
- Report Number
- 2029214-2012-00687
- Event Type
- Injury
- Date Received
- December 6, 2012
- Date of Event
- November 6, 2012
- Report Date
- November 6, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED FOR EVALUATION AND THE PUSHWIRE WAS BROKEN INTO TWO SEGMENTS. ANALYSIS OF THE CROSS SECTION AT THE BREAK POINT SHOWED THE FAILURE OF THE PUSHWIRE OCCURRED DUE TO TORSIONAL OVERLOAD. PUSHWIRE SEPARATION. (B)(4).
Description of Event or Problem · 1
PLACEMENT OF ACCESS BASILAR TIP RECANALIZATION. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PHYSICIAN TORQUED THE PUSHWIRE FIVE TIMES TO RELEASE IT FROM THE CAPTURE COIL. AFTER SUCCESSFUL PLACEMENT OF THE PIPELINE, THE PUSHWIRE WAS FOUND TO BE BROKEN AT THE DISTAL TIP ALONG WITH THE CAPTURE COIL. THE PHYSICIAN RETRIEVED THE BROKEN SEGMENT WITH A MICRO SNARE. IT WAS REPORTED THAT THE PT HAD A MINOR STROKE IN THE REGION THAT THE PIPELINE WAS PLACED, BUT HAD RECOVERED, DOING WILL, AND DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77350-20 | AP12-032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |