FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 3041553
·
Received April 8, 2013
Report
- Report Number
- 2029214-2013-00337
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 25, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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
TREATMENT OF A SUPRACLINOID ANEURYSM MEASURING 12MM. POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXHIBITED STROKE LIKE SYMPTOMS. ANGIOGRAPHY SHOWED A STROKE IN THE RIGHT HEMISPHERE AND THE PIPELINE WAS 100% THROMBOSED DUE TO IT NOT BEING FULLY EXPANDED. REOPRO AND LYTICS WERE ADMINISTERED TO THE PATIENT AND BALLOON ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE) WAS PERFORMED TO ACHIEVE FULL WALL APPOSITION. NO OTHER INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142961 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-77450-20 | 9667555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention| S |