MAUDE Adverse Event Report: B. BRAUN Z-MED; BALLOON AORTIC VALVULOPLASTY

Device Problem Insufficient Information (3190)

Patient Problems Rupture (2208); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Death  

Event Description

Medtronic received information, that a planned balloon aortic valvuloplasty (bav) of a moderately calcified annulus, using a 24mm z-med balloon, with no intent to perform a transcatheter valve implant.Resulted in severe aortic insufficiency.The physician decided to perform an emergent implant a transcatheter bioprosthetic valve.However, it was determined, there was an annular rupture from the bav.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: Z-MED
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 17532229
• MDR Text Key: 321040103
• Report Number: MW5139137
• 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: 06/07/2016

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