FDA Adverse Event
Death
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2840708
·
Received November 20, 2012
Report
- Report Number
- 2029214-2012-00657
- Event Type
- Death
- Date Received
- November 20, 2012
- Date of Event
- October 26, 2012
- Report Date
- October 26, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EVALUATED AND THE PIPELINE WAS FOUND DETACHED FROM THE CAPTURE COIL. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
TREATMENT OF A WIDE NECK RECANALIZED ANEURYSM IN THE CAROTID-END SEGMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PIPELINE WOULD NOT RELEASE FROM THE CAPTURE COIL AND WAS REMOVED FROM THE PATIENT. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77400-20 | 9596646 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Death |