FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2981275
·
Received February 27, 2013
Report
- Report Number
- 2029214-2013-00171
- Event Type
- Injury
- Date Received
- February 27, 2013
- Date of Event
- February 9, 2011
- Report Date
- February 19, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. THE OTHER DEVICE INVOLVED IN THE EVENT IS AS FOLLOWS: MODEL: FA-77450-16 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A LEFT UNRUPTURED ICA (INTERNAL CAROTID ARTERY) MEASURING 10.5MM X 5.0MM. POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD A LEFT RETINAL ISCHEMIA DUE TO EMBOLISM OF THE DISTAL OPHTHALMIC ARTERY. IT WAS REPORTED THAT THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83720 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77450-18 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Disability |