MAUDE Adverse Event Report: EDWARDS LIFESCIENCES KONECT RESILIA AORTIC VALVED CONDUIT AVC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11060A25

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2024

Event Type  Injury  

Manufacturer Narrative

H11: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was learned via the patient registry that a patient with a 25mm 11060a aortic valved conduit underwent a redo aortic valve replacement procedure after an implant duration of one (1) year, three (3) months due to unknown reasons.The explanted device was replaced with another 25mm 11060a aortic valved conduit.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19175173
• MDR Text Key: 340955250
• Report Number: 2015691-2024-03113
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103193855
• UDI-Public: (01)00690103193855(17)250913
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 11060A25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2024
• Initial Date FDA Received: 04/24/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male