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

Model Number	11060A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the instructions for use (ifu) have been reviewed, and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.Based on the information available, the most likely root cause is procedural and patient factors, including the implantation of an oversized valve and the patients poor tissue quality.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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 or Problem Description
It was reported and learned through medical records that a 25mm 11060a aortic valved conduit was explanted at implant due to bleeding.The explanted device was replaced with a 23mm 11060a aortic valved conduit.The patient was in recovery post procedure.Per medical records, patient underwent aortic dissection repair.Intraoperatively, native aortic valve leaflets were debrided sharply and a 25mm 11060a valved conduit was seated into place with coronary button reimplantation.Following cross-clamp removal, significant bleeding was noted from the left and right coronary ostium site.The heart was rearrested and both coronary ostia were tightened.However, there was still bleeding, with st changes corresponding to the rca territory.The surgeon decided to graft the rca, resolving the st changes.However, bleeding was still noted.The 11060a valve was removed and replaced with a smaller valved conduit.The right coronary ostium was noted to be in poor condition.Following cross-clamp removal, bleeding was noted to be much better.Patient was left with chest open due to coagulopathy issues.Patient tolerated the procedure and was transferred to icu in stable condition.The patient was discharged on pod #15.

• Brand Name: EDWARDS KONECT RESILIA AORTIC VALVED CONDUIT
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES, LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 23936505
• Report Number: 2015691-2025-10633
• Device Sequence Number: 9626952
• Product Code: LWR
• UDI-Device Identifier: 00690103193855
• UDI-Public: (01)00690103193855(17)280323
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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
• Operator of Device: Health Professional
• Device Model Number: 11060A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male