FDA Adverse Event
Malfunction
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3041533
·
Received April 8, 2013
Report
- Report Number
- 2029214-2013-00343
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 20, 2013
- Report Date
- March 21, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PUSHWIRE AND MARKSMAN CATHETER WERE RETURNED FOR EVALUATION WITHOUT THE PIPELINE. THE EVENT CAUSE COULD NOT BE DETERMINED AS THE PIPELINE WAS MISSING FROM THE CAPTURE COIL.(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WITH TORTUOUS VASCULATURE UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2013 INVOLVING TWO PIPELINES THAT WOULD NOT RELEASE FROM THEIR CAPTURE COILS AND WERE BOTH REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER PIPELINE.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2013-00342.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143261 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77475-20 | 9690997 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |