MAUDE Adverse Event Report: NUMED NUCLEUS; BALLOON AORTIC VALVULOPLASTY

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

On 18 february 2011, medtronic received information that during the implant of this transcatheter bioprosthetic valve, a balloon rupture (numed nucleus) occurred.Upon removal from the patient, the balloon was inspected and it was confirmed that the entire balloon was fully retrieved.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NUCLEUS
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): NUMED
• MDR Report Key: 17524879
• MDR Text Key: 321446308
• Report Number: MW5131821
• 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: 03/25/2011

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
• Patient Sequence Number: 1