FDA Adverse Event
Malfunction
Summary report: N
NEURFORM3 MICRODELIVERY STENT SYSTEM
MDR report key: 1214118
·
Received October 24, 2008
Report
- Report Number
- 2939204-2008-00511
- Event Type
- Malfunction
- Date Received
- October 24, 2008
- Date of Event
- October 18, 2008
- Report Date
- October 21, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- NJE
- PMA / PMN Number
- H020002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE TRYING TO ACCESS THE RIGHT CAROTID ARTERY, THE STENT (SUBJECT DEVICE) PREMATURELY DEPLOYED WITHIN THE GUIDE CATHETER. PATIENT IS REPORTED TO BE "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURFORM3 MICRODELIVERY STENT SYSTEM | (NJE) INTERCRANIAL STENT | NJE | BOSTON SCIENTIFIC CORP. | SNF34520 | 11913861 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |