MAUDE Adverse Event Report: BARD TRUE; BALLOON AORTIC VALVULOPLASTY

Model Number 22- MILLIMETER (MM) TRUE DILATITION BALLOON

Device Problem Migration (4003)

Patient Problem Great Vessel Perforation (2152)

Event Type  Death  

Event Description

Medtronic received information that prior to the attempted implant of a transcatheter bioprosthetic valve, a pre-implant balloon aortic valvuloplasty (bav) with a 22-millimeter (mm) balloon (true dilatation balloon) was performed.The first two attempts at the bav resulted in the balloon migrating too high.On the third attempt at the bav, the annulus ruptured.Heart compressions were then initiated.An attempt was made to implant the valve to see if it could improve the patient condition.No improvement was observed, and the patient expired.(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: 17526935
• MDR Text Key: 321038147
• Report Number: MW5133872
• 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: 05/23/2018

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: 22- MILLIMETER (MM) TRUE DILATITION BALLOON
• Patient Sequence Number: 1
• Treatment: TRANSCATHETER BIOPROSTHETIC VALVE