MAUDE Adverse Event Report: BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE; WIRE, GUIDE, CATHETER

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Type  Death  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was retrieved at 2/3 deployment and fully deployed into the descending aorta due to a drop in blood pressure.It was found that the amplatz super stiff guide wire perforated the left ventricle causing tamponade.Subsequently, the case was converted to an open chest procedure to repair the left ventricle perforation.A surgical valve was successfully implanted with no other adverse patient effects.It was reported that the valve and delivery catheter system (dcs) functioned correctly.Seven days post implant, the patient expired.It was reported the cause of death was from the left ventricle perforation and global patient deterioration.No autopsy was performed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AMPLATZ SUPER STIFF GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17533323
• MDR Text Key: 321041251
• Report Number: MW5140227
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1