MAUDE Adverse Event Report: B. BRAUN BALLOON AORTIC, VALVULOPLASTY; BALLOON AORTIC VALVULOPLASTY

Model Number Z-MED

Device Problem Malposition of Device (2616)

Patient Problems Tachycardia (2095); Rupture (2208); Pericardial Effusion (3271)

Event Type  Death  

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve, the patient went into ventricular tachycardia.A pre-implant balloon aortic valvuloplasty (bav) was performed prior to the insertion of the valve.The bav ruptured the annulus and caused a large pericardial effusion.The bav was performed with a 22 and 28-millimeter (mm) balloon (b.Braun z-med) for 3 inflations of unknown duration.The patient died the same day and no autopsy has been performed.The physician stated that the valve did not cause or contribute to the patient's death.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BALLOON AORTIC, VALVULOPLASTY
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 17526715
• MDR Text Key: 321039302
• Report Number: MW5133653
• 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: 02/02/2018

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: Z-MED
• Patient Sequence Number: 1