MAUDE Adverse Event Report: C.R. BARD TRUE; BALLOON AORTIC VALVULOPLASTY

Device Problem Positioning Problem (3009)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve, moderate-severe paravalvular leak was observed.Post implant, a balloon aortic valvuloplasty was performed with a 26 mm true balloon (non-medtronic).It was reported that the balloon was inserted between the two transcatheter bioprosthetic valves and crushed the inner valve.Severe central regurgitation was then noted and the procedure was converted to an open heart procedure.The transcatheter bioprosthetic valves were explanted and a new surgical aortic valve was successfully implanted.No other 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): C.R. BARD
• MDR Report Key: 17533356
• MDR Text Key: 321135574
• Report Number: MW5140260
• 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: 04/10/2015

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
• Patient Sequence Number: 1