FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2980178
·
Received February 27, 2013
Report
- Report Number
- 2029214-2013-00163
- Event Type
- Injury
- Date Received
- February 27, 2013
- Date of Event
- August 12, 2011
- Report Date
- February 6, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- 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).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE (B)(6) CLINICAL DATABASE. TREATMENT OF A RIGHT UNRUPTURED ICA (INTERNAL CAROTID ARTERY) SIDEWALL ANEURYSM MEASURING 7.8MM X 3.4MM. POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLURRING OF HIS LEFT PERIPHERAL AND CENTRAL VISION WHICH RESOLVED ON THE SAME DAY WITHOUT FURTHER TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85411 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77400-16 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Disability |