FDA Adverse Event
Death
Summary report: N
HYPERFORM OCCLUSION BALLOON SYSTEM
MDR report key: 3033754
·
Received April 3, 2013
Report
- Report Number
- 2029214-2013-00310
- Event Type
- Death
- Date Received
- April 3, 2013
- Date of Event
- February 12, 2013
- Report Date
- March 6, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MJN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).
Description of Event or Problem · 1
BALLOON ASSISTED COILING OF A P-COMM (POSTERIOR COMMUNICATING) ARTERY ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NECK OF THE ANEURYSM RUPTURED POSSIBLY DUE TO THE BALLOON BEING INFLATED APPROXIMATELY TEN TIMES. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO A COMPLICATION ASSOCIATED WITH THE SUBARACHNOID HEMORRHAGE AND THE DISSECTION OF THE ICA (INTERNAL CAROTID ARTERY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135773 | HYPERFORM OCCLUSION BALLOON SYSTEM | OCCLUSION BALLOON SYSTEM | MJN | EV3 NEUROVASCULAR | 104-4370 | 9674239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Death |