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

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Type  Death  

Event Description

Medtronic received information that following a transcatheter aortic valve implantation (tavi) the patient had a pericardial effusion and a left ventricle perforation caused by the amplatz extra stiff wire.Blood pressure dropped and echo confirmed effusion.The patient did not want to be converted to open surgery and subsequently expired.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AMPLATZ EXTRA STIFF GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17534696
• MDR Text Key: 321040786
• Report Number: MW5141596
• 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: 09/19/2016

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