MAUDE Adverse Event Report: BARD TRUE; BALLOON AORTIC VALVULOPLASTY

Model Number 20 MM TRUE BALLOON

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was deployed and a post-implant balloon aortic valvuloplasty (bav) was performed.The balloon (20 true balloon) ruptured during the inflation and difficulty was encountered when the balloon was brought back into the introducer in the leg.When the introducer was removed, the balloon was no longer attached to the catheter.A surgical cut down was performed to remove the balloon from the external iliac artery.No additional 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: 17523789
• MDR Text Key: 321109575
• Report Number: MW5130737
• 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: 03/06/2018

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: 20 MM TRUE BALLOON
• Patient Sequence Number: 1
• Treatment: TRANSCATHETER BIOPROSTHETIC VALVE