MAUDE Adverse Event Report: BARD TRUE; BALLOON AORTIC VALVULOPLASTY

Model Number 28MM TRUE BALLOON

Device Problems Material Perforation (2205); Output Problem (3005)

Patient Problems Cusp Tear (2656); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Event Description

Medtronic received information that following the implant of a transcatheter bioprosthetic valve, the valve appeared to be constrained and a post-implant balloon aortic valvuloplasty (bav) (28mm bard true balloon) was performed.The bav went as planned and the valve expanded.Echocardiogram then showed moderate central regurgitation and the leaflet was found to be prolapsed.It was deduced that the bav tore a leaflet of the valve.A second transcatheter bioprosthetic valve was implanted valve-in-valve and resulted in no central aortic insufficiency or pvl.No adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRUE
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): BARD
• MDR Report Key: 17530135
• MDR Text Key: 321092149
• Report Number: MW5137055
• Device Sequence Number: 1
• Product Code: OZT
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 28MM TRUE BALLOON
• Patient Sequence Number: 1
• Treatment: TRANSCATHETER BIOPROSTHETIC VALVE