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

Model Number 11500A

Device Problem Leak/Splash (1354)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/04/2022

Event Type  malfunction  

Event Description

The patient was undergoing an aortic valve replacement.After implantation of the inspiris valve, there was a moderate to severe aortic insufficiency noted on echo secondary to a leak coming from the valve leaflets.The inspiris valve was explanted and replaced with a magna valve.

• 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: 14512156
• MDR Text Key: 292727248
• Report Number: 14512156
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103195019
• UDI-Public: (01)00690103195019
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11500A
• Device Catalogue Number: 11500A29
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Sex: Male
• Patient Weight: 105 KG