FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3113748
·
Received May 15, 2013
Report
- Report Number
- 2029214-2013-00453
- Event Type
- Injury
- Date Received
- May 15, 2013
- Date of Event
- April 17, 2013
- Report Date
- April 17, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 RICA (RIGHT INTERNAL CAROTID ARTERY) ANEURYSM. IT WAS REPORTED THAT THAT PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT A YEAR AGO INVOLVING TWO PIPELINES. BOTH OF THE PIPELINES REQUIRED MANIPULATION OF THE MARKSMAN CATHETER TO RELEASE THEM FROM THEIR CAPTURE COILS.IT WAS REPORTED THAT THE ANEURYSM HAS RE-GROWN AND THE PATIENT IS CURRENTLY IN ICU (INTENSIVE CARE UNIT) WITH A HEADACHE.SAME EVENT AS MDR# 2029214-2013-00454.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214076 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77450-18 | 9528293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |