FDA Adverse Event
Death
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3073504
·
Received April 23, 2013
Report
- Report Number
- 2029214-2013-00395
- Event Type
- Death
- Date Received
- April 23, 2013
- Date of Event
- August 13, 2012
- Report Date
- April 9, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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).
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A LEFT RUPTURED SACCULAR POSTERIOR COMMUNICATING ARTERY SIDEWALL ANEURYSM MEASURING 1.8MM X 2.4MM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH AN SAH (SUBARACHNOID HEMORRHAGE). THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT AND HER MENTAL STATUS DETERIORATED AFTER THE SURGERY. THE SAH STILL REMAINS. SUBSEQUENTLY, THE PATIENT EXPIRED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175164 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77450-14 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death |