FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3140623
·
Received May 31, 2013
Report
- Report Number
- 2029214-2013-00523
- Event Type
- Injury
- Date Received
- May 31, 2013
- Date of Event
- May 8, 2013
- Report Date
- May 8, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PUSHWIRE HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
TREATMENT OF A CAROTID CAVE ANEURYSM MEASURING 10MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PUSHWIRE BROKE AND THE PIPELINE REQUIRED SOME MANIPULATION TO RELEASE FROM THE CAPTURE COIL. THE PUSHWIRE DISTAL TIP WAS RETRIEVED WITH A SNARE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241314 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77425-14 | 9681515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |