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

Model Number	11060A
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with a 27mm 11060a konect aortic valved conduit with one of the leaflets was not coapting.The konect remains implanted with leaflets cut and removed while another valve, a 23mm 11500a inspiris valve was implanted.After the konect was implanted and when coming off bypass, the patient had a wide-open aortic insufficiency.According to the echo, one of the leaflets was not closing.The surgeon opened the graft, inspected the valve and noticed one of the leaflets looked tethered.On visual inspection, she did not catch the leaflet with a suture.The surgeon checked underneath the valve and around it to make sure it was seated properly.The valve was checked extensively to see if there was anything tethering to it.There was no clue, aberrant sutures, cor-knots, and no calcifications that were near the area.The surgeon left the konect implanted but cut out the leaflets and placed a 23mm inspiris valve inside.Per surgeon she had to take big bites with the suture to sew in the inspiris valve, and the patient ended up requiring a pacemaker.There was nothing wrong with the konect valve prior to implantation.
Additional 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.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated section b5, g3.H11: corrected data: corrected section h6 (health effect - impact code).
Event or Problem Description
Per medical records, the patient was diagnosed with severely calcified bicuspid aortic valve with severe stenosis and mild insufficiency.The patient initially underwent aortic and ascending aortic replacement with a 27mm konect valved conduit composite valve graft, and laa clipping.The 27mm konect seated with no issues.A hole was made in the posterior portion of the graft.Reimplantation of the coronary arteries were performed.Cross-clamp was removed.Tee showed moderate to severe central regurgitation.It appeared to originate from the center of the valve and extended along the coaptation between the noncoronary cusp and left coronary cusp.Crossclamp was placed again.There were no sutures or calcifications along the annulus that were impinging the valve and no bioglue noted.The noncoronary leaflet appeared to be tight with a fold within the leaflet.It did not coapt well with the other two leaflets.The valve portion of the composite graft was carefully removed.The metal and plastic portions of the valve were removed, and the graft itself was left in place.Large bites with large needles were placed using pledgeted horizontal mattress sutures around the annulus.A 25mm inspiris valve was implanted without issues.The patient was taken to the icu in critical but stable condition.Per additional information from the surgeon, there was nothing wrong with the konect valve prior to implantation.
Additional Manufacturer Narrative
Customer report that "one of the leaflets was not coapting" was unable to be confirmed due to valve condition as received.As received, the valve dismantled into separated components.Two of the leaflets remained attached to the valve band and sewing ring; the third leaflet was returned detached from the rest of the valve.The metal band was deformed and plastic band was cut.The valve wireform was also returned detached from the rest of the valve.Rest of the konect device was not returned.No other visible inconsistencies were observed from the returned components.A device history record (dhr) review was performed, and no relevant non-conformances were identified.Flow and coaptation testing is performed on 100% of 11060a devices during process.The condition of the valve as received would not likely pass coaptation testing.Therefore, it is unlikely that the reported leaflets were not coapting are the result of a manufacturing nonconformance.Based on the information available, a definitive root cause cannot be conclusively determined.A potential root cause includes procedural factors with excessive manipulation during implantation.An edwards defect has not been confirmed.

• Brand Name: KONECT RESILIA AORTIC VALVED CONDUIT AVC
• 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: 23770146
• Report Number: 2015691-2025-09926
• Device Sequence Number: 9742812
• Product Code: LWR
• UDI-Device Identifier: 00690103201390
• UDI-Public: (01)00690103201390(17)280803
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 02/03/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/08/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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
• Patient Age: 69 YR
• Patient Sex: Male