MAUDE Adverse Event Report: UNKNOWN FREESTYLE AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 04/24/2023

Event Type  Injury  

Event Description

As reported by a field clinical specialist, a patient underwent a transfemoral tavr procedure with a 26mm s3ur inside a 29mm freestyle aortic valve.Once the valve was successfully implanted, the team noted a dissection in the descending aorta.A balloon pump was placed and the patient was converted to ecmo.The patient was unable to recover.Reference number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FREESTYLE AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488562
• MDR Text Key: 320688985
• Report Number: MW5121261
• Device Sequence Number: 1
• Product Code: LWR
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1