MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC. VALVE AORTIC RESILIA 23MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A23

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2022

Event Type  malfunction  

Event Description

Inspiris aortic tissue valve implanted.Valve performance checked via tee.Surgeon called cardiologist to view and discuss.After discussion inspiris aortic valve explanted.Fda safety report id# (b)(4).

• Brand Name: VALVE AORTIC RESILIA 23MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC.
• MDR Report Key: 15760344
• MDR Text Key: 303415978
• Report Number: MW5113170
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11500A23
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 69 KG