MAUDE Adverse Event Report: EDWARDS LIFESCIENCES KONECT RESILIA AORTIC VALVED CONDUIT AVC; 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	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: additional manufacturer narrative: this report serves as both the initial and final medical device report (mdr), incorporating the findings from the investigation.The device was not returned to edwards for evaluation as it remains implanted.One video was provided and reviewed.Customer report of bleeding from graft was confirmed.Video appeared to show a valve conduit implanted, a stream of clear fluid directed at the valve conduit appeared to be continuously rinsing away blood/fluid from the same general area of the conduit surface.A device history record (dhr) review was performed, and no relevant non-conformances were identified.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 complaint was confirmed as per provided imagery, however, a definitive root cause cannot be conclusively determined.An edwards defect has not been confirmed.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
Per the report received form india, edwards was notified of an event describing a bleeding from graft issue during implantation of a konect resilia aortic valved conduit model 11060a25.As reported, post-anastomosis, there was a persistent bleeding observed that seemed to come from the aortic root and the annulus.However, after approximately two (2) hours of evaluation, the bleeding source did not stop after protamine administration and was identified to be coming from the graft.As reported, the graft had been previously rinsed as per ifu prior to implantation and no deairing needle was inserted in this case (the hole in the top end of the vein was used to deair).Reportedly, the bleeding was detected to be coming from a single hole area of 1.5x0.5cm and it was arrested and managed with a suture, replacing the damaged area.It was further reported after follow-up that additional measures were required including three (3) extra units of whole blood, one (1) unit of single-donor platelets and two (2) units of clotting factors [octuplex].The patient was reported to be stable after the procedure.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 22396205
• Report Number: 2015691-2025-05440
• Device Sequence Number: 20068908
• Product Code: LWR
• UDI-Device Identifier: 00690103193855
• UDI-Public: (01)00690103193855(17)270925
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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?: Yes
• 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: 05/06/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male