MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Device Problems Retraction Problem (1536); Failure to Advance (2524); Difficult to Open or Close (2921)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve, the valve was deployed in the correct aortic position.A mild leak was reported and a balloon aortic valvuloplasty (bav) was performed with a 25 mm edward's balloon.The balloon was delivered through one of the valve struts and caused the valve to move up.The balloon became lodged in the valve and could not be released.Several attempts were made to release the valve, however, was unsuccessful.The patient had open heart surgery to remove the valve and balloon and a surgical valve was implanted.No further adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC
• MDR Report Key: 17534296
• MDR Text Key: 321138601
• Report Number: MW5141199
• Device Sequence Number: 1
• Product Code: NPT
• 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: 05/08/2017

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