FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3182092
·
Received June 21, 2013
Report
- Report Number
- 2029214-2013-00572
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 8, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
TREATMENT OF A CLINOID SEGMENT ANEURYSM MEASURING 12MM IN SIZE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PUSHWIRE TIP FRACTURED AS IT WAS BEING PULLED BACK THROUGH THE CATHETER AND REMAINS IN THE PATIENT.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282181 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77475-20 | 9432037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |