FDA Adverse Event
Injury
Summary report: N
WINGSPAN STENT SYSTEM
MDR report key: 1211588
·
Received October 23, 2008
Report
- Report Number
- 2939204-2008-00497
- Event Type
- Injury
- Date Received
- October 23, 2008
- Date of Event
- October 9, 2008
- Report Date
- October 9, 2008
- Manufacturer
- NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
- Product Code
- NJE
- PMA / PMN Number
- H050001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STENT WAS DELIVERED TO THE TARGET LESION IN THE MIDDLE CEREBRAL ARTERY (MCA) AND WAS DEPLOYED. WHEN REMOVING THE STENT SYSTEM, IT WAS FOUND THROUGH THE ANGIOGRAPHY THAT THE DUAL-TAPERED TIP HAD BROKEN OFF. THE BROKEN PART WAS RETRIEVED TOGETHER WITH THE GUIDEWIRE. IT WAS NOTED THAT THE PATIENT EXPERIENCED A "VASCULAR SPASM" DURING THE PROCEDURE AND HAS RECOVERED. PATIENT IS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WINGSPAN STENT SYSTEM | (NJE) NEROVASCULAR STENT | NJE | NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION | WE030009 | 11239165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |