FDA Adverse Event
Injury
Summary report: N
PIPELINE EMBOLIZATION DEVICE
MDR report key: 2972449
·
Received February 21, 2013
Report
- Report Number
- 2029214-2013-00139
- Event Type
- Injury
- Date Received
- February 21, 2013
- Date of Event
- January 24, 2013
- Report Date
- January 24, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
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 RIGHT, UNRUPTURED, FUSIFORM, CAV (CAVERNOUS) ANEURYSM MEASURING 14MM X 5MM. DURING THE PROCEDURE INVOLVING TWO PIPELINES, IT WAS REPORTED THAT THE FIRST PIPELINE TWISTED UPON DEPLOYMENT AND WAS REMOVED FROM THE PATIENT WHILE THE SECOND PIPELINE WAS DEPLOYED SUCCESSFULLY WITH THE HELP OF BALLOON ANGIOPLASTY TO ACHIEVE FULL WALL APPOSITION.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2013-00138.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75945 | PIPELINE EMBOLIZATION DEVICE | FLOW DIVERSION | OUT | EV3 NEUROVASCULAR | FA-71475-30 | 9658234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |