FDA Adverse Event
Injury
Summary report: N
NEUROFORM 3 STENT SYSTEM
MDR report key: 1241711
·
Received November 20, 2008
Report
- Report Number
- 2939204-2008-00625
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- November 8, 2008
- Report Date
- November 8, 2008
- Manufacturer
- NEUROVASCULAR DIVISON, BOSTON SCIENTIFIC CORPORATION
- 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
IT WAS REPORTED THAT AFTER THE STENT WAS DELIVERED TO THE TARGET ANEURYSM, THE STENT COULD NOT BE RELEASED. AFTER THE PHYSICIAN ADJUSTED THE POSITION OF THE STENT TWO TIMES, THEY FELT "SIGNIFICANT" RESISTANCE AND COULD NOT RELEASE THE STENT. WHEN THE PHYSICIAN ATTEMPTED TO ADJUST THE POSITION OF THE STENT A THIRD TIME, IT "RELEASED AUTOMATICALLY" WITH ONE END OF THE STENT INSIDE OF THE ANEURYSM. SUBSEQUENTLY, THE PHYSICIAN USED ANOTHER OF THE SAME DEVICE TO COVER THE NECK OF THE ANEURYSM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUROFORM 3 STENT SYSTEM | (NJE) NEUROVASCULAR STENT | NJE | NEUROVASCULAR DIVISON, BOSTON SCIENTIFIC CORPORATION | E325015 | 11284960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention | NEUROFORM 3 STENT SYSTEM (BOSTON SCIENTIFIC CORP) |