MAUDE Adverse Event Report: BARD TRUE BALLOON VALVULOPLASTY CATHETER; BALLOON AORTIC VALVULOPLASTY

Device Problem Insufficient Information (3190)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Event Description

Medtronic received information that following the implant of a transcatheter bioprosthetic valve, a 26mm bard true balloon damaged the commissure of the valve causing aortic regurgitation.Subsequently, a second transcatheter bioprosthetic valve was implanted.No adverse patient effects were reported.Pe (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRUE BALLOON VALVULOPLASTY CATHETER
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): BARD
• MDR Report Key: 17524400
• MDR Text Key: 321135846
• Report Number: MW5131347
• 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: 09/08/2016

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