FDA Adverse Event
Injury
Summary report: N
PIPELINE EMOBLIZATION DEVICE
MDR report key: 2902194
·
Received January 8, 2013
Report
- Report Number
- 2029214-2013-00008
- Event Type
- Injury
- Date Received
- January 8, 2013
- Date of Event
- December 10, 2012
- Report Date
- December 10, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINED IN THE PATIENT.(B)(4).
Description of Event or Problem · 1
TREATMENT OF A RIGHT UNRUPTURED OPHTHALMIC ANEURYSM MEASURING 26MM X 11MM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE FIRST PIPELINE WAS STUCK IN THE CAPTURE COIL AND REMOVED FROM THE PATIENT. A SECOND PIPELINE WAS DEPLOYED PROPERLY, BUT THE FINAL 1/3 OF THE DEVICE WOULD NOT OPEN AND DISTAL ACCESS WAS LOST. THE PIPELINE WAS LEFT INSIDE THE PATIENT AFTER FAILED ATTEMPTS TO RETRIEVE IT WITH AN ALLIGATOR RETRIEVAL DEVICE AND SNARE. NO INJURIES WERE REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE. SAME EVENT WAS MDR# 2029214-2013-00007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9419 | PIPELINE EMOBLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77450-18 | JL11-063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention| S |