FDA Adverse Event
Death
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3000550
·
Received March 12, 2013
Report
- Report Number
- 2029214-2013-00222
- Event Type
- Death
- Date Received
- March 12, 2013
- Date of Event
- December 31, 2012
- Report Date
- February 18, 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
(B)(4).
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 DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: FA-71450-30 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 2). (B)(4).
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A RIGHT UNRUPTURED FUSIFORM ICA (INTERNAL CAROTID ARTERY) OTHER C6-C7 ANEURYSM MEASURING 22MM X 22MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING THREE PIPELINES ON (B)(6) 2011 AND EXPIRED A YEAR LATER AFTER DELAYED THROMBECTOMY WAS DONE DUE TO A STROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103936 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-71350-30 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |