FDA Adverse Event
Injury
Summary report: N
NEUROFORM 3 STENT SYSTEM
MDR report key: 1211579
·
Received October 23, 2008
Report
- Report Number
- 2939204-2008-00498
- Event Type
- Injury
- Date Received
- October 23, 2008
- Date of Event
- October 16, 2008
- Report Date
- October 16, 2008
- Manufacturer
- NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP
- Product Code
- NJE
- PMA / PMN Number
- H020002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS UNDERGOING A STENT ASSISTED COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM LOCATED IN THE LEFT INTERAL CAROTID ARTERY (ICA). STENT DELIVERY WAS "DIFFICULT" AS THE LESION WAS CURVED AND THE STENT PREMATURELY DEPLOYED BEFORE REACHING THE TARGET LESION. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT COMPLICATIONS. PATIENT IS "STABLE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUROFORM 3 STENT SYSTEM | (NJE) NEUROVASCULAR STENT | NJE | NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP | E335020 | 11598156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |