FDA Adverse Event Injury Summary report: N

WINGSPAM STENT SYSTEM

MDR report key: 696752 · Received April 5, 2006

Report

Report Number
6000078-2006-00093
Event Type
Injury
Date Received
April 5, 2006
Date of Event
January 20, 2006
Report Date
April 3, 2006
Manufacturer
BOSTON SCIENTIFIC CORP, NEUROVASCULAR
Product Code
NIO
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
OR, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

BOSTON SCIENTIFIC CORP BECAME AWARE THAT THE PT UNDERWENT SUCCESSFUL TREATMENT OF A VERTEBRAL ARTERY ANEURYSM 2006. A FEW DAYS LATER THE PT DEVEOPED HEMORHAGE (STROKE) OF THE LEFT FRONTAL LOBE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 WINGSPAM STENT SYSTEM INTRAVASCULAR STENT NIO BOSTON SCIENTIFIC CORP, NEUROVASCULAR * 7987652

Patients

Seq Age Sex Outcome Treatment
1 * Death