FDA Adverse Event Death Summary report: N

MICRO THERAPEUTICS, INC.

MDR report key: 580494 · Received March 8, 2005

Report

Report Number
580494
Event Type
Death
Date Received
March 8, 2005
Date of Event
February 22, 2005
Report Date
March 8, 2005
Manufacturer
MICRO THERAPEUTICS, INC.
Product Code
MJN
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

DURING A CEREBRAL ANGIOPLASTY, A 6 F MPC GUIDE CATHETER WAS PLACED INTO THE RIGHT VERTEBRAL ARTERY AND CONNECTED TO A CONTINUOUS INFUSION OF HEPARINIZED SALINE SOLUTION. TRANSCATHETER INFUSION OF 5 MG OF VERAPAMIL WAS PERFORMED. A FOLLOW-UP CEREBRAL ANGIOGRAM OF THE RIGHT VERTEBRAL ARTERY DEMONSTRATED SOME MILD IMPROVEMENT OF THE DISTAL PERFUSION BUT WITH RESIDUAL NARROWING OF THE BASILAR ARTERY. A HYPERGLIDE 4X10 BALLOON CATHETER WAS PREPARED ON THE BACK TABLE AND THEN PLACED INTO THE GUIDE CATHETER AND ADVANCED INTO THE DISTAL RIGHT VERTEBRAL ARTERY FOLLOWED BY THE BASILAR ARTERY. WITH THE BALLOON POSITIONED IN THE DISTAL BASILAR ARTERY AND GUIDE WIRE THROUGH THE DISTAL TIP INTO THE RIGHT POSTERIOR CEREBRAL ARTERY, ATTEMPTED INFLATION OF THE BALLOON WAS PERFORMED USING A 60% MIXTURE OF CONTRAST. THE BALLOON WAS NOT VISUALIZED AND THEREFORE THE GUIDEWIRE WAS PULLED BACK INTO THE CATHETER AND INFUSION OF THE CONTRAST WAS PERFORMED THROUGH THE CATHETER. DURING THIS INFLATION, THE BALLOON WAS MONITORED USING FLUOROSCOPY. IT WAS THEN NOTED THAT THE BALLOON WAS INFLATING DESPITE THE GUIDEWIRE BEING POSITIONED WITHIN THE CATHETER. A CEREBRAL ANGIOGRAM WAS PERFORMED ON THE RIGHT VERTEBRAL ARTERY DEMONSTRATING NO SIGNIFICANT FLOW INTO THE VERTEBROBASILAR SYSTEM. THIS INDICATED A RUPTURE OF THE BLOOD VESSEL WITH INTRACRANIAL HEMORRHAGE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MICRO THERAPEUTICS, INC. HYPERGLIDE BALLOON CATHETER MJN MICRO THERAPEUTICS, INC. * 950170

Patients

Seq Age Sex Outcome Treatment
1 52 YR Death