FDA Adverse Event
Malfunction
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3953854
·
Received July 23, 2014
Report
- Report Number
- 2029214-2014-00427
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- June 26, 2014
- Report Date
- June 26, 2014
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
TREATMENT OF A SMALL ANEURYSM MEASURING 12MM X 6MM LOCATED IN THE CAVERNOUS SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE (4.50MM X 16MM) WOULD NOT COME OFF THE CAPTURE COIL. IT WOULD NOT PLUMP AND WOULD ONLY RESHEATH. THE PIPELINE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS ABORTED DUE TO HEMATOMA IN THE GROIN AREA. THE PATIENT WAS REPORTED TO BE DOING WELL AND THE PROCEDURE WILL BE RESCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431473 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77450-16 | 9922640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |