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

Device Problems Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Death  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve the patient became hypotensive and cardiopulmonary resuscitation (cpr) was initiated.An echocardiogram revealed a pericardial effusion.A sternotomy was performed and showed a perforation of the posterior and lateral wall of the left ventricle.The perforation was suspected to be caused by the improper shape of the boston amplatz super stiff guidewire.The valve had dislodged into the sinus of valsalva resulting in aortic regurgitation.A second valve was implanted successfully.The patient was transferred on extracorporeal membrane oxygenation (ecmo) and subsequently expired later that night.(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: 17530721
• MDR Text Key: 321041913
• Report Number: MW5137639
• 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: 01/29/2016

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