MAUDE Adverse Event Report: NUMED NUMED Z-MED II, 25-04-100; BALLOON AORTIC VALVULOPLASTY

Lot Number 611769

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271); Cardiovascular Insufficiency (4445); Valvular Insufficiency/ Regurgitation (4449)

Event Type  Injury  

Event Description

Medtronic received information that prior to implanting this transcatheter bioprosthetic valve, when balloon aortic valvuloplasty was performed (numed z-med ii, 25-04-100, lawson# (b)(4)), perforation of the aortic annulus and left ventricle free wall occurred.There was immediate hemodynamic collapse, requiring closed chest massage and pericardiocentesis.Emergent closure of left ventricle rupture and surgical aortic valve replacement was performed.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NUMED Z-MED II, 25-04-100
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): NUMED
• MDR Report Key: 17527689
• MDR Text Key: 321088860
• Report Number: MW5134621
• 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: 04/08/2011

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 Lot Number: 611769
• Patient Sequence Number: 1