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

Model Number 11500A

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

Device did not work properly after implanted, moderate central jet present.Manufacturer response for heart-valve, non-allograft tissue, (inspiris resilla aortic valve), (per site reporter).Manufacturer will be sending out a kit and return label to return the defective product.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 14266034
• MDR Text Key: 290533222
• Report Number: 14266034
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 11500A
• Device Catalogue Number: 11500A23MM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 95 KG